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The effect of communication on pain


- candidate number25190
- NTR NumberNTR5994
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-aug-2016
- Secondary IDsNL55225.041.16; ABR number: 55225 METC Utrecht
- Public TitleThe effect of communication on pain
- Scientific TitleExamining the effects of enhanced provider-patient communication on post-operative pain; an RCT performed in daily clinical care
- ACRONYMNA
- hypothesisMore specifically, the goals of this research project are in subsequent order:
1. To examine whether adult patients following tonsillectomy in the enhanced outcome expectancy condition will experience less pain (and other outcomes), compared to patients in the standard condition.
2. To examine whether adult patients following tonsillectomy in the enhanced empathy communication condition will experience less pain (and other outcomes) compared to patients in the standard empathy communication condition.
3. To examine the interaction effects of the different levels of outcome expectancy and empathy on adult patients¡¯ experiences of pain and other outcomes.
- Healt Condition(s) or Problem(s) studiedTonsillotomy
- Inclusion criteria- Scheduled for tonsillectomy in daycare
- ¡İ18 years of age
- Speaking and understanding of the Dutch language
- Having mental capacity
- Exclusion criteriaAt study start (during inclusion process):
- Not scheduled for tonsillectomy in daycare
- <18 years of age
- Not speaking and understanding of the Dutch language
- Lacking mental capacity (cognitive decline, dementia). During study: - Patients who experience a post-operative bleeding will be excluded. - The health professionals involved and investigators can decide to withdraw a subject from the study for urgent medical reasons (e.g. if patients are not discharged on the day of operation due to complications).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-aug-2016
- planned closingdate31-jul-2017
- Target number of participants128
- InterventionsPatients are randomly assigned to 1 of the 4 groups:
1) enhanced empathy + enhanced expectations
2) enhanced exmpathy + standard expectations
3) standard empathy + enhanced expectations
4) standard empathy + standard expectations.
In each group the communication of the nurses will be in line with group assignment.
The standard medical care will be the same for all patients.
- Primary outcomePain intensity: Patients¡¯ pain will be assessed on the basis of Numeric Rating Scale (NRS).
- Secondary outcomePain related: e.g. Pain expectations, overal benefit of analgesia, analgesic dosage, analgesic request, general pain evaluation, general experiences/expectations/attitudes medications, general reporting of pain, perceived expectation. Psychosocial: e.g. perceived empathy, state anxiety, mood, satisfaction, general evaluations regarding hospitalization, attitudes towards medication.
Data from medical record: e.g. medical background data. Adherence to communication manipulation protocol (via taped interactions).
- TimepointsData is collected at several timepoints (not all outcomes are collected at all timepoints):
- Pre-hospitalization
- During hospitalization (pre-peri- and post-operation)
- Post-hospitalization: day 2
- Post hospitalization: day 3
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMsc. Liesbeth Vliet, van
- CONTACT for SCIENTIFIC QUERIESMsc. Liesbeth Vliet, van
- Sponsor/Initiator NIVEL
- Funding
(Source(s) of Monetary or Material Support)
NWO, SPINOZA-award Prof. dr. J. M. Bensing
- Publications
- Brief summaryBackground of the study:
Placebo effects are true biopsychological effects that arise from the overall clinical context. Placebo effects can be attributed to several mechanisms, such as expectancy manipulation and empathy provision by means of the practitioners¡¯ communication. The latter mechanism has received little attention in the literature so far. Moreover, the distinct effects of both mechanisms are unclear from current clinical studies. In previous experimental studies we have started to disentangle both mechanisms in highly controlled settings, but there is a need to test and potentially validate these mechanisms in the clinical setting of doctor-patient communication research.

Objective of the study:
The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during pre- and post-operative tonsillectomy analgesia care on clinical adult patients¡¯ outcomes (main outcome measures is pain perception).

More specifically, the goals of this research project are in subsequent order:
1. To examine whether adult patients following tonsillectomy in the enhanced outcome expectancy condition will experience less pain (and other outcomes), compared to patients in the standard condition.
2. To examine whether adult patients following tonsillectomy in the enhanced empathy communication condition will experience less pain (and other outcomes) compared to patients in the standard empathy communication condition.
3. To examine the interaction effects of the different levels of outcome expectancy and empathy on adult patients¡¯ experiences of pain and other outcomes.

Study design:
A four-arm (2x2 design) single-blind randomized controlled trial will be conducted at nursing wards. Nurses who provide pre- and post-operative (analgesic) care to adult patients undergoing tonsillectomy will systematically manipulate their communication. Patients will be randomly assigned to one of the 4 arms, which vary in the induction of expectations (standard vs enhanced), and (the level of) nurses¡¯ communication of empathy/affect (standard vs enhanced).

Study population:
Patients who are scheduled for tonsillectomy in daycare, ¡İ18 years of age, speaking and understanding of the Dutch language, having mental capacity.

Intervention (if applicable):
Patients are randomly assigned to 1 of the 4 groups:
1) enhanced empathy + enhanced expectations
2) enhanced exmpathy + standard expectations
3) standard empathy + enhanced expectations
4) standard empathy + standard expectations.
In each group the communication of the nurses will be in line with group assignment.
The standard medical care will be the same for all patients.

Primary study parameters/outcome of the study:
Pain intensity: Patients¡¯ pain will be assessed on the basis of Numeric Rating Scale (NRS).

Secundary study parameters/outcome of the study (if applicable):
Pain related: e.g. Pain expectations, overal benefit of analgesia, analgesic dosage, analgesic request, general pain evaluation, general experiences/expectations/attitudes medications, general reporting of pain, perceived expectation. Psychosocial: e.g. perceived empathy, state anxiety, mood, satisfaction, general evaluations regarding hospitalization, attitudes towards medication.
Data from medical record: e.g. medical background data. Adherence to communication manipulation protocol (via taped interactions).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Patients will complete until day 3 extra questionnaires, which will take in total approximately 50 minutes (prehospitalization (approx 20 min); post-operation (approx 5min), day 2 post-hospitalization (approx 5 min), day 3 study end (approx 20 min). Participants receive usual care with regard to surgery, analgesic therapy and postoperative treatment. The communication manipulation will be provided on top of the standard care. Although practitioners¡¯ communication is deliberately manipulated, we will ensure the communication manipulation will not be harmful for patients nor will it affect the psychological integrity of patients.
- Main changes (audit trail)
- RECORD22-aug-2016 - 22-jan-2017


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