Health TrialsbyHealthPanel

iPAWS: Improving Pain Management After Wisdom Tooth Extraction Surgery

ConditionsPain, PostoperativeSubstance Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-20
SponsorBrown University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Educational Materials

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: iPAWS InterventionExperimental treatment 2 interventions
Group B: Educational MaterialsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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%.

Time frame
End of active treatment phase (6 weeks)
2

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%.

Time frame
End of active treatment phase (6 weeks)

Secondary outcomes

1

Number of cannabis use days

Number of days that participants consumed cannabis over the last 3 weeks (weeks 4-6 of treatment) will be measured by the Timeline Followback Interview.

Time frame
Last 3 weeks of active treatment phase (weeks 4-6)
2

Pain intensity

Average pain intensity is assessed during daily Ecological Momentary Assessments using the Numerical Rating Scale (NRS) . This is assessed on a scale from 0 (no pain) to 10 (most pain possible). Minimum value= 0 and maximum value=10. Higher scores indicate higher levels of pain (i.e. worse outcome). Analysis will examine average pain levels after treatment (weeks 4-6).

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

Substance use craving

Substance use craving is measured during daily Ecological Momentary Assessments using an item validated in past work: "How strong is your urge to use substances right now? This includes marijuana, alcohol, nicotine, and other drugs." This is assessed on scale from 0 (no urge) to 10 (strongest urge ever). Minimum value= 0 and maximum value=10 and higher scores indicate higher levels of craving (i.e. worse outcomes). Analysis will examine responses to this item after treatment (weeks 4-6).

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

Abstinent days

Abstinent days (proportion of days on which no cannabis use is reported) during the last 3 weeks (treatment weeks 4-6). The analysis will control for baseline (defined as proportion of abstinent days in the two weeks preceding the treatment).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brown University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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