Sorry Not Sorry: Apologizing and Its Effect on Discomfort During Dressing Removal
1 other identifier
interventional
25
1 country
1
Brief Summary
Use of dressing is common place following surgery, allowing for wounds to be covered and protected. Dressing material with adhesive contact layers or adhesive tape is integral to sealing off the wound. Mechanical stripping of stratum corneum during dressing removal causes pain and discomfort. During dressing removal, practitioners may at times apologize as a function of empathy. Previous study investigated speed of dressing removal and its effect on discomfort during dressing change. In this study, the investigators aim to investigate how empathy expressed in form of saying "sorry" affect the perception of pain during dressing change?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedStudy Start
First participant enrolled
March 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedOctober 11, 2018
October 1, 2018
6 months
July 11, 2017
October 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain
Based on self reported 10 point visual analog scale
Immediate
Study Arms (2)
Sorry
EXPERIMENTALA small strip of self-adhesive dressing (3cm by 4cm) will be applied to the back of the patients' participants' hand and side of neck. After one minute of acclimatization, the dressing will be removed by the examiner. During the removal, the examiner will say sorry repeatedly. Following the dressing removal, participant will rate their pain with a 10 point visual analog scale.
Not Sorry
NO INTERVENTIONA small strip of self-adhesive dressing (3cm by 4cm) will be applied to the back of the patients' participants' hand and side of neck. After one minute of acclimatization, the dressing will be removed by the examiner. During the removal, the examiner will remain silent. Following the dressing removal, participant will rate their pain with a 10 point visual analog scale.
Interventions
The objective of this study is to investigate how empathy expressed in form of saying "sorry" affect the perception of pain during dressing change?
Eligibility Criteria
You may qualify if:
- Healthy adult volunteers, age \>18.
You may not qualify if:
- individuals with sensitivity to tape or dressing, anxiety disorders, or pain syndromes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Science Centre - Victoria Hospital
London, Ontario, N6A5W9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle MacNeil, MD
London Health Science Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 13, 2017
Study Start
March 6, 2018
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
October 11, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share