iPAWS: Improving Pain Management After Wisdom Tooth Extraction Surgery

NCT07731295 | Recruiting DMC

• 2 other identifiers: STUDY000006621K23DA053411
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Substance Use

Outcome Measures

Primary Outcomes (2)

• Number of participants who complete the active treatment phase (feasibility)

  The number of participants who complete the active treatment phase will determine feasibility. The treatment will be considered feasible if the number of participants who complete treatment is ≥ 70%.

  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)

  The Client Satisfaction Questionnaire (CSQ-8) which ranges in scores from 8 to 32 will determine acceptability. Higher scores indicate higher satisfaction (i.e. better outcomes). Treatment will be considered acceptable if the number and percentage of participants who rate their experience either "satisfactory" or "highly satisfactory is ≥ 80%.

  End of active treatment phase (6 weeks)

Secondary Outcomes (6)

• Number of cannabis use days

  Last 3 weeks of active treatment phase (weeks 4-6)

• Pain intensity

  Last 3 weeks of active treatment phase (weeks 4-6)

• Substance use craving

  Last 3 weeks of active treatment phase (weeks 4-6)

• Abstinent days

  Last 3 weeks of active treatment phase (weeks 4-6)

• Pain intereference

  Last 3 weeks of active treatment phase (weeks 4-6)

Study Arms (2)

iPAWS Intervention

EXPERIMENTAL

Participants in the experimental condition will receive standard practice educational materials and the iPAWS self-guided, digital intervention.

Behavioral: iPAWS; Other: Educational Materials

Educational Materials

ACTIVE COMPARATOR

Participants in the control condition will receive standard practice educational materials (i.e., in the form of a brochure).

Other: Educational Materials

Interventions

iPAWS BEHAVIORAL

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.

iPAWS Intervention

Educational Materials OTHER

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.

Educational Materials; iPAWS Intervention

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- N/A

Sponsors & Collaborators

• Brown University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Melissa Pielech, PhD

CONTACT

401-863-6583; melissa_pielech@brown.edu

Kristin Rogers, MS

CONTACT

401-863-6463; kristin_rogers@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 28, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-05

Locations

US (1)