Does Choice Improve the Pain Relief Derived From a Brief Intervention

NCT06582758 | Completed

• 1 other identifier: STUDY00004916_MOD5065
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience.

Conditions

Pain; Acute Pain

Keywords

mindfulness

Outcome Measures

Primary Outcomes (1)

• Change in Pain Unpleasantness Numeric Rating Scale

  Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.

  Immediately before to after 7 to 10-minute audio recording

Secondary Outcomes (2)

• Change in Pain Intensity Numeric Rating Scale

  Immediately before to after 7 to 10-minute audio recording

• Change in Anxiety Numeric Rating Scale

  Immediately before to after 7 to 10-minute audio recording

Study Arms (4)

Mindful Pain Management (randomized)

EXPERIMENTAL

In the control mindful pain management intervention, participants will be randomized to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.

Behavioral: Mindful Pain Management

Pain Psychoeducation (randomized)

ACTIVE COMPARATOR

In the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.

Behavioral: Pain Psychoeducation

Choice: Mindful Pain Management

EXPERIMENTAL

In the choice mindful pain management intervention, participants will choose to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.

Behavioral: Mindful Pain Management

Choice: Pain Psychoeducation

ACTIVE COMPARATOR

In the choice pain psychoeducation intervention, participants will choose to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.

Behavioral: Pain Psychoeducation

Interventions

Pain Psychoeducation BEHAVIORAL

In the pain psychoeducation intervention, participants will be provided a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.

Choice: Pain Psychoeducation; Pain Psychoeducation (randomized)

Mindful Pain Management BEHAVIORAL

In the mindful pain management intervention, participants will listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.

Choice: Mindful Pain Management; Mindful Pain Management (randomized)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving pain treatment at Tallahassee Orthopedic Center
• Understanding English instructions fluently
• Being 18 years of age or older

You may not qualify if:

• Unable to consent because of physical or mental incapacity.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, 32308, United States

Location

MeSH Terms

Conditions

Pain; Acute Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: September 4, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)