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Pain After Tonsillectomy Study

NCT03538730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-10-15

No results posted yet for this study

Summary

Pain is a common experience in childhood. Healthy children can undergo up to 20 painful procedures by the age of 5. Moreover, millions of children undergo surgery (e.g., tonsillectomies) each year, which is commonly linked to pain and distress. Pain from, and fear of, medical experiences are not short lasting. Indeed, they can influence children long after the painful situation is over. Children's memories of pain after surgery can affect painful experiences in the future. Negative memories of pain (when children remember more pain than the actual level of pain experienced) are linked to higher pain and distress. As well, children who are more anxious and who experience greater pain are more likely to develop negatively biased pain memories, which then leads to greater fear and pain at subsequent pain experiences. It has been suggested that the ways in which parents and children talk about pain following painful events is important for how children remember the pain.

This study will be one of the first to look at whether a parent-led memory reframing intervention can reduce children's negative memories of surgery.

The study will include 100 children scheduled for a tonsillectomy and one of their parents. They will be recruited from the Alberta Children's Hospital. Parents will complete a survey 1-3 weeks before their child's surgery, and then the child's pain and anxiety will be monitored on the day of surgery and for 2 weeks after surgery. Two weeks after surgery, the parent and child will come to the hospital and be assigned to a control group or a memory reframing session. Six weeks after surgery, parents and children will complete a telephone interview.

Conditions

  • Pain, Postoperative

Interventions

BEHAVIORAL

Memory Reframing

The intervention will draw from existing narrative-based interventions, past pain memory reframing interventions and findings from our recent data. Specifically, parents will be taught to reminisce with their children about the in-hospital and post-surgery periods by encouraging children to provide more explanations, using less utterances about pain, avoiding repetitions, emphasizing positive aspects of the child's surgery memory (e.g., when children used coping methods such as deep breathing, when they got a treat), and enhancing children's self-efficacy regarding their ability to cope with pain.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Melanie Noel, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03538730 on ClinicalTrials.gov