Trial Outcomes & Findings for A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures. (NCT NCT02690194)

Results Overview

Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

Pre-therapy/pre-procedure

Results posted on

2018-12-21

Participant Flow

Control group data was not analyzed for all measures

Participant milestones

Participant milestones
Measure	Placebo Group 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Overall Study STARTED	17	18	19
Overall Study COMPLETED	16	14	19
Overall Study NOT COMPLETED	1	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Group 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Overall Study Withdrawal by Subject	1	4	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=16 Participants 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group n=14 Participants 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group n=19 Participants 1. Pre-Procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=16 Participants	1 Participants n=14 Participants	2 Participants n=19 Participants	5 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=16 Participants	8 Participants n=14 Participants	10 Participants n=19 Participants	29 Participants n=49 Participants
Age, Categorical >=65 years	3 Participants n=16 Participants	5 Participants n=14 Participants	7 Participants n=19 Participants	15 Participants n=49 Participants
Age, Continuous	50.9 years STANDARD_DEVIATION 18.0 • n=16 Participants	53.9 years STANDARD_DEVIATION 15.8 • n=14 Participants	55.5 years STANDARD_DEVIATION 17.1 • n=19 Participants	52.4 years STANDARD_DEVIATION 2.12 • n=49 Participants
Sex: Female, Male Female	10 Participants n=16 Participants	11 Participants n=14 Participants	14 Participants n=19 Participants	35 Participants n=49 Participants
Sex: Female, Male Male	6 Participants n=16 Participants	3 Participants n=14 Participants	5 Participants n=19 Participants	14 Participants n=49 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Pre-therapy/pre-procedure

Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg

Outcome measures

Outcome measures
Measure	Placebo Group n=16 Participants 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group n=14 Participants 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group n=19 Participants 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure BP-Systolic	121.9 mmHg Standard Deviation 17.5	121.9 mmHg Standard Deviation 9.5	127.3 mmHg Standard Deviation 14.1
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure BP-Diastolic	77.2 mmHg Standard Deviation 10.8	78.9 mmHg Standard Deviation 8.1	82.2 mmHg Standard Deviation 11.3

PRIMARY outcome

Timeframe: Pre-therapy/pre-procedure

Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.

Outcome measures

Outcome measures
Measure	Placebo Group n=16 Participants 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group n=14 Participants 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group n=19 Participants 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Pre-therapy/Pre-procedure Stress Level Measured by Pulse	75.6 Beats per minute Standard Deviation 14.3	66.4 Beats per minute Standard Deviation 14.4	69.5 Beats per minute Standard Deviation 11.2

PRIMARY outcome

Timeframe: Pre-therapy/pre-procedure

Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.

Outcome measures

Outcome measures
Measure	Placebo Group n=16 Participants 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group n=14 Participants 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group n=19 Participants 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate	16.1 Breaths per minute Standard Deviation 3.0	14.0 Breaths per minute Standard Deviation 2.1	14.4 Breaths per minute Standard Deviation 2.1

PRIMARY outcome

Timeframe: Pre-therapy/pre-procedure

Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.

Outcome measures

Outcome measures
Measure	Placebo Group n=16 Participants 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group n=14 Participants 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group n=19 Participants 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Pre-therapy/Pre-procedure Anxiety Level S-Anxiety Score	33.1 score on a scale Standard Deviation 7.2	34.4 score on a scale Standard Deviation 10.9	31.4 score on a scale Standard Deviation 7.1
Pre-therapy/Pre-procedure Anxiety Level T-Anxiety Score	35.6 score on a scale Standard Deviation 6.1	34.0 score on a scale Standard Deviation 7.6	32.4 score on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: Post-therapy/pre-procedure

Population: No data were collected for the control group in this Outcome Measure

Post-therapy/pre-procedure change in stress level measured by pulse in beats per minute. Value at prost-therapy/pre-procedure minus value at pre-therapy/pre-procedure.

Outcome measures

Outcome measures
Measure	Placebo Group n=16 Participants 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group n=14 Participants 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse	-0.11 Beats per minute Interval -8.1 to 7.8	3.48 Beats per minute Interval -5.1 to 12.1	—

SECONDARY outcome

Timeframe: Post-therapy/pre-procedure

Population: No data were collected for the control group in this Outcome Measure.

Post-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.

Outcome measures

Outcome measures
Measure	Placebo Group n=16 Participants 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group n=14 Participants 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate	-0.14 Breaths per minute Interval -0.78 to 0.51	-0.70 Breaths per minute Interval -1.4 to 0.0	—

SECONDARY outcome

Timeframe: Post-therapy/pre-procedure

Population: No data were collected for the control group in this Outcome Measure.

Post-therapy/Pre-procedure change in anxiety level measure by the State-Trait Anxiety Inventory. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.

Outcome measures

Outcome measures
Measure	Placebo Group n=16 Participants 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group n=14 Participants 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Post-therapy/Pre-procedure Change in Anxiety Level S-Anxiety Score	-2.82 score on a scale Interval -8.4 to 2.7	-12.3 score on a scale Interval -18.3 to -6.3	—
Post-therapy/Pre-procedure Change in Anxiety Level T-Anxiety Score	-8.44 score on a scale Interval -15.2 to -1.7	-3.92 score on a scale Interval -11.2 to 3.4	—

SECONDARY outcome

Timeframe: Post-therapy/Pre-procedure

Population: No data were collected for the control group in this Outcome Measure.

Post-therapy/pre-procedure change in stress level measured by blood pressure measured in mmHg. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.

Outcome measures

Outcome measures
Measure	Placebo Group n=16 Participants 1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Placebo Group: The placebo group will wear headphones and listen to nature sounds.	Experimental (Buddhify) Group n=14 Participants 1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.	Control Group 1. Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PROCEDURE 3. Post-procedure -Rate pain level of procedure
Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure BP-Systolic	3.9 mmHg Interval -3.5 to 11.3	-1.1 mmHg Interval -9.1 to 6.9	—
Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure BP-Diastolic	7.0 mmHg Interval 1.5 to 12.4	-1.2 mmHg Interval -7.1 to 4.7	—

SECONDARY outcome

Timeframe: Immediately post-procedure

Perceived pain level of the procedure as assessed by the Wong-Baker FACES pain rating scale 1-10. A score of 1 indicates "no hurt" (a better outcome) while a score of 10 indicates "hurts worst" (worst outcome).