iPAWS: Improving Pain Management After Wisdom Tooth Extraction Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iPAWS, Educational Materials.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Substance Use. Basic parameters: 15 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is a clinical trial that will evaluate the feasibility and acceptability of a virtual brief program for adolescents and young adults undergoing wisdom tooth extraction and their parents. The program aims to teach youth safe and effective ways to manage post-surgical pain as well as decrease risky health behaviors.
Interventions
- Behavioral iPAWS
The brief intervention (named iPAWS) will be an integration of evidence-based brief interventions for AYA SU (e.g. MET-CBT) and acute pain coping (CBT). The intervention is brief, readily accessible, developmentally tailored, applicable to single and poly-SU and scalable to other acutely painful procedures to meet the need for effective, accessible, and scalable SU interventions at key entry points of clinical care. - Other Educational Materials
Participants will be given a digital copy of a brochure from the American Dental Association on "Wisdom Teeth Management" (included in attachments). The investigator will also mail the participant a hard copy of the brochure, if requested.
Primary outcome measures
- Number of participants who complete the active treatment phase (feasibility) [Time frame: End of active treatment phase (6 weeks)]
- Number of participants who rate their treatment experience in the "satisfactory" or "highly satisfactory" range on the Client Satisfaction Questionnaire (Acceptability) [Time frame: End of active treatment phase (6 weeks)]
Secondary outcome measures (6)
- Number of cannabis use days [Time frame: Last 3 weeks of active treatment phase (weeks 4-6)]
- Pain intensity [Time frame: Last 3 weeks of active treatment phase (weeks 4-6)]
- Substance use craving [Time frame: Last 3 weeks of active treatment phase (weeks 4-6)]
- Abstinent days [Time frame: Last 3 weeks of active treatment phase (weeks 4-6)]
- Pain intereference [Time frame: Last 3 weeks of active treatment phase (weeks 4-6)]
- Pain coping strategies [Time frame: Last 3 weeks of active treatment phase (weeks 4-6)]
Eligibility criteria
Inclusion criteria
- Ages 15 to 20 years
- Undergoing wisdom tooth extraction for the first time
- Able to read simple English
- \*Endorse cannabis use at least two days per week on average in the past 28 days
\*The investigator aims to recruit at least 50 participants who are using cannabis at least two days per week in the past 28 days on average and will recruit up to 100 additional participants who use other substances, use cannabis at a lesser intensity, or do not use any substances.
- (Parent/Guardian only) - Have a child who is undergoing wisdom tooth surgery and is participating in the study
Exclusion criteria
\- N/A
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brown University Center for Alcohol and Addiction Studies — Providence
Identifiers
NCT: NCT07731295 · STUDY00000662 · 1K23DA053411