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…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain intensity: Patients* pain will be assessed on the basis of Numeric Rating
Scale (NRS).
Secondary outcome
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).
Background summary
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.
Study objective
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).
Intervention
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.
Study burden and risks
Patients will complete until day 3 extra questionnaires, which will take in
total approximately 50 minutes (pre-hospitalization (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.
Otterstraat 118-124
Utrecht 3513 CR
NL
Otterstraat 118-124
Utrecht 3513 CR
NL
Listed location countries
Age
Inclusion criteria
Patients:
- Scheduled for tonsillectomy in daycare
- *18 years of age
- Speaking and understanding of the Dutch language
- Having mental capacity;(nurses who will deliver the intervention will also be asked to provide informed consent).
Exclusion criteria
At 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). ;If patients drop-out, their data until exclusion will be included in the analyses, unless a patient objects to this (this will be asked upon exclusion)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL55225.041.16 |
| OMON | NL-OMON28669 |