Reframe the Pain: A Parent-Led Intervention to Alter Children's Memories for Pain

NCT03110367 | Completed

• 1 other identifier: REB17-0426
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is a common experience in youth and influences youth long after the painful situations are over. Youth memory of pain after surgery can affect painful experiences in the future. Negative memories and feelings of pain, like remembering more pain than the actual level of pain experienced are linked to anxiety for future surgery. Research has found that children's memories of pain is linked to anxiety, pain-related fear, and confidence. Children's memories for pain can be altered after a visit to the hospital, but only a couple of studies have look at this. The study will be one of the first to look at how well a parent-led memory reframing intervention to reduce youth's negative memories of surgery. We want to look at how a parent-led memory reframing session on youth's post-surgical pain memory. The study will include 90 youth who have a chest wall surgery or a spinal fusion surgery at the Alberta Children's Hospital. They will be recruited at the Alberta Children's Hospital. There will be pain tests in the form of surveys 1-3 weeks before surgery, pain monitoring in the hospital for a couple of days, pain monitoring 1-2 weeks after surgery, a clinic visit 2-4 weeks after surgery for a memory reframing session, and pain monitoring 6 weeks after surgery in the form of a telephone interview.

Conditions

Psychology; Pain; Stress; Behavior; Coping; Emotion, Expressed

Outcome Measures

Primary Outcomes (1)

• Memory Biases

  Youth and parents will complete telephone memory interviews to assess their pain memories. Specifically, youth will be asked to remember the levels of sensory (pain intensity) and affective (unpleasantness, anxiety) pain experienced after the surgery. Parents will be asked to remember the levels of sensory (pain intensity) and affective (unpleasantness, anxiety) pain they think their children experienced after the surgery. At the beginning of the memory interviews, children and parents will be asked to freely recall anything that they can remember about the pain task. Telephone interviews to assess children's memory for pain have been effectively conducted with youth. Positively biased pain memories will be defined as recalled pain level that is less than the initial pain report. Accurate memories reflect no difference between recalled and experienced pain. Free recall will be coded for both content and tone.

  4 weeks post-operative (for spinal instrumentation surgeries) - 6 weeks post operative (for pectus chest wall surgeries)

Secondary Outcomes (30)

• Sleep Quality - Child

  At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)

• Sleep quality - Parent

  At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)

• Pain Intensity

  At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries), telephone interview (6 weeks post operative)

• Pain characteristics, unpleasantness, and interference.

  At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)

• Pain-related anxiety.

  At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries), telephone interview (6 weeks post operative)

Study Arms (3)

Pain Reframing Intervention

ACTIVE COMPARATOR

Participants will be randomized into this group: \- Memory reframe with parent facilitated by researcher: Parents and youth in the intervention group will receive instructions about adaptive ways of reminiscing about the in-hospital and post-surgery periods. The intervention will draw from existing narrative-based interventions that have taught parents to reminisce with their children about past negative events in more elaborative and emotion-rich ways.

Behavioral: Pain Reframing Intervention

Attention Control Group

SHAM COMPARATOR

Participants will include 90 youth scheduled for a pectus repair or a spinal fusion surgery, surgeries associated with high levels of post-surgical pain, and their parents. They will be recruited at the Alberta Children's Hospital. The timelines and measures to be administered to parents and children are listed below. The timelines will include a baseline assessment (1-3 weeks pre-op), in hospital assessment for several days, 1-2 weeks post-op (acute recovery phase), the 2-4 week post-op clinic visit (memory reframing intervention) and 6 weeks post-op. Participants will be randomized into this group: \- Attention control (watch video \[Planet Earth\] for same amount of time): Parents and youth in the attention control group will watch a neutral 20-minute video that is not related to surgery (Planet Earth). Importantly, they will not talk about pain or the past surgery experience.

Behavioral: Attention Control Group

Normal Reminiscing

NO INTERVENTION

Participants will include 90 youth scheduled for a pectus repair or a spinal fusion surgery, surgeries associated with high levels of post-surgical pain, and their parents. They will be recruited at the Alberta Children's Hospital. The timelines and measures to be administered to parents and children are listed below. The timelines will include a baseline assessment (1-3 weeks pre-op), in hospital assessment for several days, 1-2 weeks post-op (acute recovery phase), the 2-4 week post-op clinic visit (memory reframing intervention) and 6 weeks post-op. Participants will be randomized into this group: \- Normal Reminiscing: Parents and youth in the normal reminiscing group will be instructed to reminisce with their children about the in-hospital and post-surgery periods as they normally would.

Interventions

Pain Reframing Intervention BEHAVIORAL

Parents and youth in the intervention group will receive instructions about adaptive ways of reminiscing about the in-hospital and post-surgery periods. The intervention will draw from existing narrative-based interventions that have taught parents to reminisce with their children about past negative events in more elaborative and emotion-rich ways (e.g., using more open-ended questions, to follow in on children's answers by providing new details about the event, to talk more about emotions, and to praise children's answers).

Pain Reframing Intervention

Attention Control Group BEHAVIORAL

Parents and youth in the attention control group will watch a neutral 20-minute video that is not related to surgery (Planet Earth). Importantly, they will not talk about pain or the past surgery experience.

Attention Control Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth between the age of 10 to 18
• Youth who are scheduled to have a chest wall surgery or a spinal fusion surgery

You may not qualify if:

• Youth with developmental disorders or who are being treated for cancer
• Youth who have had a chest wall surgery or spinal fusion surgery before
• Youth who are scheduled for other surgical procedures within 24 hours of the scheduled chest wall surgery or spinal fusion surgery
• Youth who do not speak fluent English
• Youth who have two non-fluent English speaking parents (one parent must be fluent in English to participate)
• Youth who experience chronic pain

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, Sun J, Katz J, Brindle M, Noel M. A memory-reframing intervention to reduce pain in youth undergoing major surgery: Pilot randomized controlled trial of feasibility and acceptability. Can J Pain. 2022 Jun 9;6(2):152-165. doi: 10.1080/24740527.2022.2058919. eCollection 2022.

  PMID: 35711298 DERIVED

MeSH Terms

Conditions

Pain; Behavior

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of Calgary

Model Details: Participants will include 90 youth scheduled for a pectus repair or a spinal fusion surgery, surgeries associated with high levels of post-surgical pain, and their parents. They will be recruited at the Alberta Children's Hospital. The timelines and measures to be administered to parents and children are listed below. The timelines will include a baseline assessment (1-3 weeks pre-op), in hospital assessment for several days, 1-2 weeks post-op (acute recovery phase), the 2-4 week post-op clinic visit (memory reframing intervention) and 6 weeks post-op. Participants will be randomized into three groups: 1. Attention Control Group 2. Normal Reminiscing 3. Intervention Group

Study Record Dates

• First Submitted: March 18, 2017
• First Posted: April 12, 2017
• Study Start: January 23, 2018
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)