Pain After Tonsillectomy Study

NCT03538730 | Completed

• 1 other identifier: REB17-1794
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Memory

  Children will complete a pain memory interview via telephone where they will be asked to recall the in-hospital and post-surgery (i.e., while at home) time periods and complete the same pain intensity and pain-related fear scales based on their memories of those time periods. Biases in memory will be defined as the deviation in recalled and initial/experienced pain reports. Similar to our previous research, statistical models predicting pain memories will control for initial pain ratings that correspond to each memory question. Negatively biased pain memories will be defined as children who remember more pain and fear as compared to their initial pain reports. Positively biased pain memories will be defined as recalled pain that is less than initial pain reports. Accurate memories reflect no difference between recalled and experienced levels of pain.

  3-4 weeks post-surgery

Secondary Outcomes (22)

• Child preoperative anxiety

  Day of surgery

• Child pain intensity

  Day of surgery, days 1, 2, 3, 7, and 14 post-surgery, 3-4 weeks post-surgery

• Child pain-related fear

  Day of surgery, days 1, 2, 3, 7, and 14 post-surgery, 3-4 weeks post-surgery

• Parent self-efficacy

  1 week pre-surgery, 2 weeks post-surgery

• Child sleep quality

  1 week pre-surgery, 2 weeks post-surgery

Study Arms (2)

Attention Control

NO INTERVENTION

Similar to previous narrative and memory interventions, parents in the control group will receive instructions from a researcher for 20 minutes on how to engage in child-directed play. Importantly, they will not talk about pain or the past surgery experience.

Memory Reframing Intervention

EXPERIMENTAL

Parents in the intervention group will spend 20 minutes with a researcher and receive instructions about adaptive ways of reminiscing about the in-hospital and post-surgery periods.

Behavioral: Memory Reframing

Interventions

Memory Reframing BEHAVIORAL

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.

Memory Reframing Intervention

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Scheduled to undergo an elective outpatient tonsillectomy with or without adenoidectomy

You may not qualify if:

• Children receiving pre-medication with anxiolytics (Midazolam; administered to \< 5% of youth),
• who have serious medical co-morbidities,
• and/or who have developmental disabilities or speech/language delays

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (1)

• Pavlova M, Lund T, Nania C, Kennedy M, Graham S, Noel M. Reframe the Pain: A Randomized Controlled Trial of a Parent-Led Memory-Reframing Intervention. J Pain. 2022 Feb;23(2):263-275. doi: 10.1016/j.jpain.2021.08.002. Epub 2021 Aug 21.

  PMID: 34425247 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Melanie Noel, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Group allocation will be revealed to one investigator at the outset of the lab visit. Other investigators and participants will remain masked until the end of the memory interview. Outcome assessors will remain masked for the duration of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: At 2-weeks post-surgery, parent-child dyads will participate in a lab visit during which time they will be randomized into an intervention or control group. Randomization will be conducted by an external statistician using a computer random number generator. Allocation concealment will be achieved using sequentially numbered, opaque, and sealed envelopes.

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: May 29, 2018
• Study Start: January 12, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)