Trial Outcomes & Findings for My Surgical Success: A Randomized Controlled Pilot Study of a Pre-surgical Psychological Intervention (NCT NCT03076190)
NCT ID: NCT03076190
Last Updated: 2024-04-22
Results Overview
Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Means and Standard Deviations are reported per the table below.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
Immediately post-treatment
Results posted on
2024-04-22
Participant Flow
4 participants declined to participate; 127 were randomized
Participant milestones
| Measure |
Active Control Group (Health Education)
Prior to surgery:
* Demographics survey
* Baseline surveys
* Participants receive online information regarding nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery.
* Follow-up questions about the handouts (detailed above)
Post-surgery:
* Daily surveys (detailed above)
* Follow-up surveys (2, 4, 8, and 12 weeks after surgery)
|
My Surgical Success Treatment Group
Prior to surgery:
* Demographics survey
* Baseline surveys
* Intervention:
* 90-minute psychoeducational My Surgical Success video that emphasizes catastrophizing treatment.
* audio file
* personalized plan that incorporates the information learned in the video.
* Follow-up questions about the video (detailed above)
Post-surgery:
* Daily surveys (detailed above)
* Follow-up surveys (2, 4, 8, and 12 weeks after surgery)
Psychoeducational My Surgical Success Video: The 90-minute video includes instruction by Dr. Beth Darnall, PhD, a pain psychologist at the Stanford Pain Management Center. She teaches the viewer about the relationship between stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, decrease stress, and increase relaxation.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
77
|
|
Overall Study
COMPLETED
|
32
|
36
|
|
Overall Study
NOT COMPLETED
|
18
|
41
|
Reasons for withdrawal
| Measure |
Active Control Group (Health Education)
Prior to surgery:
* Demographics survey
* Baseline surveys
* Participants receive online information regarding nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery.
* Follow-up questions about the handouts (detailed above)
Post-surgery:
* Daily surveys (detailed above)
* Follow-up surveys (2, 4, 8, and 12 weeks after surgery)
|
My Surgical Success Treatment Group
Prior to surgery:
* Demographics survey
* Baseline surveys
* Intervention:
* 90-minute psychoeducational My Surgical Success video that emphasizes catastrophizing treatment.
* audio file
* personalized plan that incorporates the information learned in the video.
* Follow-up questions about the video (detailed above)
Post-surgery:
* Daily surveys (detailed above)
* Follow-up surveys (2, 4, 8, and 12 weeks after surgery)
Psychoeducational My Surgical Success Video: The 90-minute video includes instruction by Dr. Beth Darnall, PhD, a pain psychologist at the Stanford Pain Management Center. She teaches the viewer about the relationship between stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, decrease stress, and increase relaxation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
34
|
|
Overall Study
Excluded from Analysis (zero duration ev
|
9
|
7
|
Baseline Characteristics
Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
Baseline characteristics by cohort
| Measure |
Active Control Group (Health Education)
n=32 Participants
Prior to surgery:
* Demographics survey
* Baseline surveys
* Participants receive online information regarding nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery.
* Follow-up questions about the handouts (detailed above)
Post-surgery:
* Daily surveys (detailed above)
* Follow-up surveys (2, 4, 8, and 12 weeks after surgery)
|
My Surgical Success Treatment Group
n=36 Participants
Prior to surgery:
* Demographics survey
* Baseline surveys
* Intervention:
* 90-minute psychoeducational My Surgical Success video that emphasizes catastrophizing treatment.
* audio file
* personalized plan that incorporates the information learned in the video.
* Follow-up questions about the video (detailed above)
Post-surgery:
* Daily surveys (detailed above)
* Follow-up surveys (2, 4, 8, and 12 weeks after surgery)
Psychoeducational My Surgical Success Video: The 90-minute video includes instruction by Dr. Beth Darnall, PhD, a pain psychologist at the Stanford Pain Management Center. She teaches the viewer about the relationship between stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, decrease stress, and increase relaxation.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants • Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
|
0 Participants
n=30 Participants • Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
|
0 Participants
n=61 Participants • Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=31 Participants • Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
|
27 Participants
n=30 Participants • Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
|
54 Participants
n=61 Participants • Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
|
|
Age, Categorical
>=65 years
|
4 Participants
n=31 Participants • Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
|
3 Participants
n=30 Participants • Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
|
7 Participants
n=61 Participants • Overall number of baseline participants represents the number of participants whose ages we had and are not a reflection of how many participants we collected data on. We had missing demographic data on these participants.
|
|
Age, Continuous
|
51.16 years
STANDARD_DEVIATION 11.45 • n=31 Participants • One participant from the control group and 6 participants from the treatment group had missing demographic data
|
51.27 years
STANDARD_DEVIATION 11.14 • n=30 Participants • One participant from the control group and 6 participants from the treatment group had missing demographic data
|
51.21 years
STANDARD_DEVIATION 11.20 • n=61 Participants • One participant from the control group and 6 participants from the treatment group had missing demographic data
|
|
Sex: Female, Male
Female
|
32 Participants
n=32 Participants
|
36 Participants
n=36 Participants
|
68 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=32 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=32 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=32 Participants
|
10 Participants
n=36 Participants
|
13 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=32 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=32 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=32 Participants
|
20 Participants
n=36 Participants
|
43 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=32 Participants
|
6 Participants
n=36 Participants
|
9 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
36 participants
n=36 Participants
|
68 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Immediately post-treatmentParticipants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Means and Standard Deviations are reported per the table below.
Outcome measures
| Measure |
Active Control Group
n=32 Participants
Health Education Active Control Group
|
My Surgical Success Treatment Group
n=36 Participants
My Surgical Success Intervention Group
|
|---|---|---|
|
Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning
Easy to Understand
|
5.9 units on a scale
Standard Deviation .3
|
5.9 units on a scale
Standard Deviation .2
|
|
Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning
Relevant
|
4.7 units on a scale
Standard Deviation 1.51
|
5.0 units on a scale
Standard Deviation 1.6
|
|
Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning
Useful
|
4.67 units on a scale
Standard Deviation 1.52
|
5.1 units on a scale
Standard Deviation 1.3
|
|
Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning
Satisfaction
|
4.67 units on a scale
Standard Deviation 1.56
|
5.2 units on a scale
Standard Deviation 1.2
|
|
Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning
Likely to Use
|
5.03 units on a scale
Standard Deviation 1.3
|
5.3 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Before surgery to post-surgicallyPopulation: Before Surgery
Pain Catastrophizing Scale is a validated 13-item measure assessing levels of pain catastrophizing. Scores range from 0-52, with a higher score indicating higher levels of pain catastrophizing. Data below presents total scores on the scale.
Outcome measures
| Measure |
Active Control Group
n=32 Participants
Health Education Active Control Group
|
My Surgical Success Treatment Group
n=36 Participants
My Surgical Success Intervention Group
|
|---|---|---|
|
Group Difference in Within-subject Pain Catastrophizing
|
8.24 score on a scale
Standard Error 1.19
|
6.62 score on a scale
Standard Error 1.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Data on opioid use was collected for the 4 month duration of the studyPostsurgical opioid stop date was self-reported by patients. The opioid stop date was collected through the two-, four-, eight-, and 12-week follow-up surveys with the question "On what date did you stop taking your opioid medication?" The number of postsurgical days using opioids was calculated by subtracting the opioid stop date from the surgery date obtained in the medical chart. Statistical analyses present the data in mean number of days to opioid cessation in each group.
Outcome measures
| Measure |
Active Control Group
n=32 Participants
Health Education Active Control Group
|
My Surgical Success Treatment Group
n=36 Participants
My Surgical Success Intervention Group
|
|---|---|---|
|
Group Difference in Time to Opioid Cessation
|
21.83 Days to opioid cessation
Standard Error 4.11
|
11.19 Days to opioid cessation
Standard Error 2.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to post-surgery (up to 4 months duration of the study)PROMIS scores for physical function and pain interference will be reported post-surgically. All PROMIS assessments were converted from raw scores to t-scores (Mean= 50, SD=10). Higher scores on PROMIS pain interference signify greater severity of pain interfering with patient's functioning. However, higher scores on Physical function reflects a greater level of physical functioning. The investigators will conduct within subject analyses and will report pre-post treatment changes.
Outcome measures
| Measure |
Active Control Group
n=32 Participants
Health Education Active Control Group
|
My Surgical Success Treatment Group
n=36 Participants
My Surgical Success Intervention Group
|
|---|---|---|
|
Group Difference in Post-surgical PROMIS Physical Function and PROMIS Pain Interference
Pain Interference
|
4.31 score on a scale
Standard Deviation 9.65
|
6.77 score on a scale
Standard Deviation 9.31
|
|
Group Difference in Post-surgical PROMIS Physical Function and PROMIS Pain Interference
Physical Health
|
2.56 score on a scale
Standard Deviation 6.41
|
0.72 score on a scale
Standard Deviation 6.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe investigators will report the baseline psychosocial scores (PROMIS measures) for patients who report high satisfaction with the My Surgical Success treatment. Pain Intensity Scale ranges from 0 (no Pain) to 10 (the worst pain imaginable), with higher scores indicating worse pain. Total scores range from 0-10. Pain Catastrophizing Scale is a 13-item measure assessing levels of pain catastrophizing. Scores range from 0-52, with a higher score indicating higher levels of pain catastrophizing. All PROMIS assessments were converted from raw scores to t-scores (M= 50, SD=10). There are no minimum and maximum values as these are standardized scores. PROMIS Pain Intensity, Pain Interference, Physical Function, Depression, Anxiety, were administered at baseline. Higher scores on PROMIS depression, anxiety, pain interference, and pain intensity signify greater severity of these symptoms. However, higher scores on Physical Function reflects a greater level of physical functioning.
Outcome measures
| Measure |
Active Control Group
n=36 Participants
Health Education Active Control Group
|
My Surgical Success Treatment Group
My Surgical Success Intervention Group
|
|---|---|---|
|
Characterize Responders to My Surgical Success (Demographics and Psychological Correlates)
Pain Intensity
|
1.47 score on a scale
Standard Deviation 1.12
|
—
|
|
Characterize Responders to My Surgical Success (Demographics and Psychological Correlates)
Pain Catastrophizing
|
7.33 score on a scale
Standard Deviation 1.3
|
—
|
|
Characterize Responders to My Surgical Success (Demographics and Psychological Correlates)
PROMIS physical functioning
|
37.52 score on a scale
Standard Deviation 5.42
|
—
|
|
Characterize Responders to My Surgical Success (Demographics and Psychological Correlates)
PROMIS Pain Interference
|
47.49 score on a scale
Standard Deviation 1.59
|
—
|
|
Characterize Responders to My Surgical Success (Demographics and Psychological Correlates)
PROMIS Depression
|
47.15 score on a scale
Standard Deviation 1.29
|
—
|
|
Characterize Responders to My Surgical Success (Demographics and Psychological Correlates)
PROMIS Anxiety
|
54.49 score on a scale
Standard Deviation 1.48
|
—
|
Adverse Events
Active Control Group (Health Education)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
My Surgical Success Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place