Trial Outcomes & Findings for Enriched Environments in Endometriosis (NCT NCT04179149)

Last Updated: 2025-05-23

Results Overview

Mean level of maximum pain using the Visual Analog Scale (VAS), in which 1 is no pain and 10 is the worst pain imaginable. Categories: 1-4 low pain; 5-7 moderate pain; 8-10 severe pain. Therefore, the higher the score in the VAS the higher the pain level.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

at baseline, at end of the intervention and 3 months after the end of intervention

Results posted on

2025-05-23

Participant Flow

We completed recruitment for both study cohorts of cases and controls. We started patient recruitment in September 2019 via a social media campaign and regular media (newspaper articles, radio, TV). Printed flyers and posters were distributed among local gynecology offices. Our targeted recruitment was 60 subjects per study group or 120 subjects total for both sessions. By the start of the study we recruited 29 patients in the intervention group and 27 in the control group.

Participant milestones

Participant milestones
Measure	Environmental Enrichment Subjects randomized to the intervention condition will receive the Environmental Enrichment (EE) intervention (social support, open spaces, novel stress relief activities) as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Environmental enrichment: The experimental group will participate in six modules that mimic and integrate the three hallmarks of Environmental Enrichment: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention	Controls Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period in addition on participation in an online patient training module.
Overall Study STARTED	29	27
Overall Study COMPLETED	12	27
Overall Study NOT COMPLETED	17	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enriched Environments in Endometriosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Environmental Enrichment n=29 Participants Subjects randomized to the intervention condition will receive the EE intervention (social support, open spaces, novel stress relief activities) as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Environmental enrichment: The experimental group will participate in six modules that mimic and integrate the three hallmarks of EE: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention	Controls n=27 Participants Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period PLUS an online patient training module. They were visited by members of the study team twice at their homes or preset meeting place to obtain samples and surveys.	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.7 years STANDARD_DEVIATION 6.677 • n=5 Participants	34.0 years STANDARD_DEVIATION 7.638 • n=7 Participants	33.34 years STANDARD_DEVIATION 7.123 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	29 Participants n=5 Participants	27 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Puerto Rico	29 participants n=5 Participants	27 participants n=7 Participants	56 participants n=5 Participants
pelvic pain	29 Participants n=5 Participants	25 Participants n=7 Participants	54 Participants n=5 Participants
Dyspareunia	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Baseline pelvic pain levels	8 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants	6.4 units on a scale STANDARD_DEVIATION 3.3 • n=7 Participants	7.2 units on a scale STANDARD_DEVIATION 2.9 • n=5 Participants
Perceived stress (PSS14)	32.5 units on a scale STANDARD_DEVIATION 5.7 • n=5 Participants	28.0 units on a scale STANDARD_DEVIATION 4.4 • n=7 Participants	30.3 units on a scale STANDARD_DEVIATION 5.6 • n=5 Participants

PRIMARY outcome

Timeframe: at baseline, at end of the intervention and 3 months after the end of intervention

Population: The total of participants is not equal to the total number of participants enrolled because not all participants completed this particular questionnaire of the several instruments they had to complete.

Outcome measures

Outcome measures
Measure	Environmental Enrichment n=27 Participants Subjects randomized to the intervention condition will receive the EE intervention (social support, open spaces, novel stress relief activities) as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Environmental enrichment: The experimental group will participate in six modules that mimic and integrate the three hallmarks of EE: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention	Controls n=22 Participants Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period PLUS an online patient training module.
Pain Perception Baseline	7.0 units on a scale Standard Deviation 2.8	6.2 units on a scale Standard Deviation 3.4
Pain Perception End of intervention	7.2 units on a scale Standard Deviation 1.7	5.1 units on a scale Standard Deviation 3.0
Pain Perception 3-months after	6.3 units on a scale Standard Deviation 2.4	6.6 units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: at baseline, at end of the intervention and 3 months after the end of intervention (for intervention); at baseline and end of intervention (for controls)

Population: The total of participants is not equal to the total number of participants enrolled because not all participants completed this particular questionnaire out of the many instruments that they needed to complete; also not all completed the Follow up End of intervention questionnaire in the control group (16 out of 19 participants).

QoL global impact scores measured using the Endometriosis Health Profile 30 (EHP-30), a disease-specific questionnaire to measure health related quality of life. The EHP-30 was developed by Jones et al., in 2001. Part 1 The first part contains 30 questions relevant to all women with endometriosis covering five areas: pain, emotional well-being, control and powerlessness, social support and self imaging scales. Each domain score is calculated by dividing the total scores of each item in the domain by the maximum possible score of all items in the domain multiplied by 100. Our outcome of interest is the global impact score, calculated as the mean of all completed subscale scores, with a range of 0 to 100. The global impact score ranges from 0 (indicating the best health status) to 100 (indicating the worst health status). No subscales are reported.

Outcome measures

Outcome measures
Measure	Environmental Enrichment n=26 Participants Subjects randomized to the intervention condition will receive the EE intervention (social support, open spaces, novel stress relief activities) as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Environmental enrichment: The experimental group will participate in six modules that mimic and integrate the three hallmarks of EE: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention	Controls n=19 Participants Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period PLUS an online patient training module.
Quality of Life (QoL) Baseline	61.0 score on a scale Standard Deviation 13.5	60.1 score on a scale Standard Deviation 18
Quality of Life (QoL) End of intervention	56.6 score on a scale Standard Deviation 16.0	56.2 score on a scale Standard Deviation 11.5
Quality of Life (QoL) 3-months after	50.9 score on a scale Standard Deviation 11.0	—

SECONDARY outcome

Timeframe: at baseline, at end of the intervention and 3 months after the end of intervention (for the intervention); at baseline and end of the intervention (for controls)

Perceived stress levels will be measured using the Perceived Stress Scale 14 at baseline, end of interventions and 3 months from the end of intervention for the intervention group, but only at baseline and end of the intervention for the control group. The survey asks the following 14 questions about stressful situations and helps determine what stress is to the participant and how stressful they feel their life to be. Higher scores indicate higher levels of stress. The 14 items are scored from 0 to 4. Total scores range from 0 to 56. Score categories are: Low Stress (scores 0 - 18) Moderate Stress (scores 19 - 37) High Stress (scores 38 - 56)

Outcome measures

Outcome measures
Measure	Environmental Enrichment n=27 Participants Subjects randomized to the intervention condition will receive the EE intervention (social support, open spaces, novel stress relief activities) as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Environmental enrichment: The experimental group will participate in six modules that mimic and integrate the three hallmarks of EE: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention	Controls n=22 Participants Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period PLUS an online patient training module.
Perceived Stress Levels 14 Baseline	30.0 score on a scale Standard Deviation 5.8	28.8 score on a scale Standard Deviation 5.8
Perceived Stress Levels 14 End of intervention	28.2 score on a scale Standard Deviation 5.3	27.5 score on a scale Standard Deviation 6.1
Perceived Stress Levels 14 3 months after	25.7 score on a scale Standard Deviation 5.3	—

SECONDARY outcome

Timeframe: at baseline, at end of the intervention and 3 months after the end of intervention; and at baseline and post-intervention for the control group.

Population: The total of participants is not equal to the total number of participants enrolled because not all participants completed this particular questionnaire out of the many instruments they were asked to complete; also not all participants completed the follow up questionnaires at the end of the intervention or at 3 months after (only for the intervention group)

The Patient Health Questionnaire-8 (PHQ-8) is a validated self-report tool used to assess the severity of depressive symptoms over the previous two weeks. The PHQ-8 includes 8 items, each scored on a 4-point scale: 0 = Not at all 1. = Several days 2. = More than half the days 3. = Nearly every day Total score range: 0 to 24 Directionality: Higher scores indicate greater depressive symptom severity (i.e., worse outcomes). Interpretation of total scores: 0-4: None to minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-24: Severe depression The PHQ-8 was assessed at baseline, immediately post-intervention, and at 3-month follow-up for the intervention group, and at baseline and post-intervention for the control group.

Outcome measures

Outcome measures
Measure	Environmental Enrichment n=29 Participants Subjects randomized to the intervention condition will receive the EE intervention (social support, open spaces, novel stress relief activities) as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Environmental enrichment: The experimental group will participate in six modules that mimic and integrate the three hallmarks of EE: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention	Controls n=27 Participants Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period PLUS an online patient training module.
Depressive Symptomatology Baseline	10.8 score on a scale Standard Deviation 4.5	11.3 score on a scale Standard Deviation 5.9
Depressive Symptomatology End of intervention	9.0 score on a scale Standard Deviation 4.7	8.9 score on a scale Standard Deviation 5.2
Depressive Symptomatology 3 months after	6.9 score on a scale Standard Deviation 4.0	—

SECONDARY outcome

Timeframe: at baseline, at end of the intervention and 3 months after the end of intervention (for the intervention group) and at baseline and end of the intervention (for the control group)

Population: The total of participants is not equal to the total number of participants enrolled because not all participants completed this particular questionnaire out of many instruments they were asked to complete.

General Anxiety Disorder 7 (GAD-7) survey assessed at baseline, end of intervention and 3 months from the end of intervention. The GAD-7 scores were also represented with clinical categorizations of anxiety levels as follows: GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe).

Outcome measures

Outcome measures
Measure	Environmental Enrichment n=29 Participants Subjects randomized to the intervention condition will receive the EE intervention (social support, open spaces, novel stress relief activities) as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Environmental enrichment: The experimental group will participate in six modules that mimic and integrate the three hallmarks of EE: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention	Controls n=27 Participants Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period PLUS an online patient training module.
Anxiety Symptomatology Baseline	11.7 score on a scale Standard Deviation 4.7	10.9 score on a scale Standard Deviation 6.2
Anxiety Symptomatology End of intervention	8.9 score on a scale Standard Deviation 4.2	10.1 score on a scale Standard Deviation 6.6
Anxiety Symptomatology 3 months after	6.9 score on a scale Standard Deviation 4.1	—

Adverse Events

Environmental Enrichment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Environmental Enrichment n=29 participants at risk Subjects randomized to the intervention condition will receive the EE intervention (social support, open spaces, novel stress relief activities) as an adjuvant to standard gynecological care consisting of hormonal, analgesic or surgical treatment as necessary according to their symptoms during the study period. Environmental enrichment: The experimental group will participate in six modules that mimic and integrate the three hallmarks of EE: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention	Controls n=27 participants at risk Participants randomized to the control condition will receive only standard care as necessary according to their symptoms during the study period PLUS an online patient training module.
Skin and subcutaneous tissue disorders skin reaction	3.4% 1/29 • Number of events 1 • Six (6) months Definition of adverse events is in accord with the clinical trials website guidelines.	0.00% 0/27 • Six (6) months Definition of adverse events is in accord with the clinical trials website guidelines.

Additional Information

Dr. Idhaliz Flores

Ponce Research Institute, Ponce Health Sciences University

Phone: 787-840-2575

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place