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Development and evaluation of an online version of the Feeling Better pain management programme for children and their caregivers

Development and evaluation of an online version of the Feeling Better pain management programme for children and their caregivers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58820406
Enrollment
60
Registered
2019-03-25
Start date
2016-01-05
Completion date
Unknown
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any type of paediatric chronic pain Signs and Symptoms Other chronic pain

Interventions

Assessments are completed independently by children and parents at baseline before randomization, upon completion of the 9-week intervention and at a three-month follow-up period. Varying block alloca

Sponsors

National University of Ireland Galway
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged age 5 to 12 years 2. Experienced chronic or recurrent non-malignant pain present for a period of 3 months or more which met the criteria for a diagnosis of chronic or recurrent pain as defined by the International Association for the Study of Pain (IASP, 1986) 3. Experienced pain at least once per week 4. Experienced pain interference in at least one area of daily functioning as per parent report 5. Could read and write English 6. Had regular access to a computer with an Internet connection 7. Agreed not to engage in psychological treatment for chronic pain management during the active phase of participation

Exclusion criteria

Exclusion criteria: 1. The child had a serious psychiatric illness 2. The child had pain associated with a chronic medical condition (e.g. cancer) 3. The child had a developmental disability which would prevent them understanding the research materials 4. The parent or child was non-English speaking 5. The family did not have regular access to the Internet on a computer or portable device e.g. tablet or laptop computer

Design outcomes

Primary

MeasureTime frame
Feasibility and clinical outcome assessments were carried out at baseline (T1), at post-treatment (T2, 9-11 weeks) and at three-month follow-up (T3). The primary feasibility outcome measures for this study are: 1. Recruitment measured by the percentage of eligible participants who progressed from initial enquiry to treatment allocation and enrolment. 2. Retention to follow-up measured by the completeness of online data collection in each arm at post-intervention and 3- month follow-up. This will be presented as a percentage of the participants randomised. 3. Treatment compliance measured at 9-11 weeks post-randomisation by means of objective system usage data (‘participant access data’). Website use and treatment engagement were measured in the following ways: 3.1. The number of sessions completed (0-18 total) . treatment compliance) 3.2. The number of times users logged in (‘unique logins’) 3.3. The average length of time users remained logged in 3.4. The number of times individual pages were viewed 3.5. The number of interactive strategies completed 3.6. The number of participants who submitted weekly homework 3.7. The most and least accessed website components based on the module page accessed and completion rates 4. Treatment satisfaction and acceptability measured using the Internet Evaluation and Utility Questionnaire (Thorndike et al., 2008). This measure was used at T2 / post-intervention only. 5. Website satisfaction measured using six purposely constructed questions based on Ritterband’s model for intervention development (Ritterband et al., 2009). This measure was used at T2 / post-intervention only. 6. Treatment expectancies: post-randomisation, children and parents completed a measure of treatment expectancies which comprised of a

Secondary

MeasureTime frame
Feasibility and clinical outcome assessments were carried out at baseline (T1), at post-treatment (T2, 9-11 weeks) and at three-month follow-up (T3). 1. Mood assessed by children and parents using the Pediatric Quality of Life Inventory – psychological health subscale-(PedsQL™ 4.0; Varni, 1998). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group. 2. Child health-related quality of life assessed using the Pediatric Quality of Life Inventory -(PedsQL™ 4.0; Varni, 1998). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group. 3. Child use of strategies to cope with pain measured using the Pediatric Quality of Life Inventory – Coping Skills Inventory (PedQL-CSI; Varni, 1996). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group. 4. Level of catastrophizing assessed with the Pain Catastrophising Scale-Child and Parent versions (PCS-C&P; Crombez et al., 2003). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group. 5. Pain-related self-efficacy assessed using the Self-efficacy for Functioning Despite Pain Scale – Child and Parent report (Bursch et al., 2006). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group. Levels of parental protective behaviour assessed using the Adult Response to Children’s Symptoms–Protect Subscale- child and parent versions (Walker, Ley & Whitehead, 2006). This measure was used at each point of assessment for the intervention group and at baseline and post-intervention for the control group. 6. Socio-demographic characte

Countries

Canada, Ireland, United Kingdom, United States of America

Contacts

Public ContactAngeline Traynor
a.traynor2@nuigalway+353 (0)91 493101

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026