Examining the effects of enhanced provider-patient communication on post-operative pain; an RCT performed in daily clinical care

Completed

Conditions: removal of tonsils
tonsillectomy
10019190

Registration Number: NL-OMON45805

Lead Sponsor: IVE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 128

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain intensity: Patients* pain will be assessed on the basis of Numeric Rating<br /><br>Scale (NRS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pain related: e.g. Pain expectations, overal benefit of analgesia, analgesic<br /><br>dosage, analgesic request, general pain evaluation, general<br /><br>experiences/expectations/attitudes medications, general reporting of pain,<br /><br>perceived expectation.<br /><br>Psychosocial: e.g. perceived empathy, state anxiety, mood, satisfaction,<br /><br>general evaluations regarding hospitalization, attitudes towards medication.<br /><br>Data from medical record: e.g. medical background data.<br /><br>Adherence to communication manipulation protocol (via taped interactions). </p><br>