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

October 9, 2018 updated by: Peng You, London Health Sciences Centre
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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5W9
        • London Health Science Centre - Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult volunteers, age >18.

Exclusion Criteria:

  • individuals with sensitivity to tape or dressing, anxiety disorders, or pain syndromes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Immediate
Based on self reported 10 point visual analog scale
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Health Sciences Centre

Investigators

  • Principal Investigator: Danielle MacNeil, MD, London Health Science Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2018

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 109333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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