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Sorry Not Sorry: Apologizing and Its Effect on Discomfort During Dressing Removal

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ClinicalTrials.gov Identifier: NCT03216629
Recruitment Status : Completed
First Posted : July 13, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Peng You, London Health Sciences Centre

Study Description
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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?

Condition or disease Intervention/treatment Phase
Bandages Pain Empathy Behavioral: Saying "sorry" Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sorry Not Sorry: Apologizing and Its Effect on Discomfort During Dressing Removal
Actual Study Start Date : March 6, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sorry
A 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.
 Behavioral: Saying "sorry"
The objective of this study is to investigate how empathy expressed in form of saying "sorry" affect the perception of pain during dressing change?
No Intervention: Not Sorry
A 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.


Outcome Measures
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Primary Outcome Measures :
  1. Pain [ Time Frame: Immediate ]
    Based on self reported 10 point visual analog scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult volunteers, age >18.

Exclusion Criteria:

  • individuals with sensitivity to tape or dressing, anxiety disorders, or pain syndromes.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216629


Locations
Canada, Ontario
London Health Science Centre - Victoria Hospital
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
London Health Sciences Centre
Investigators
Principal Investigator: Danielle MacNeil, MD London Health Science Centre
More Information
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Responsible Party: Peng You, MD, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03216629     History of Changes
Other Study ID Numbers: 109333
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peng You, London Health Sciences Centre:
Pain
Empathy
Dressing change