A Novel Therapeutic Approach to Treat Chronic Pelvic Pain

NCT05467241 | Completed

• 1 other identifier: 4818
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To collect pilot data and assess the feasibility of a trial employing a single-arm intervention to study the effects of combined self-induced therapeutic tremors plus mindfulness on symptoms of chronic pelvic pain among women diagnosed with chronic pelvic pain.

Conditions

Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Feasibility of the pilot trial

  To determine feasibility, the investigators will assess if it is possible to recruit, enroll, and have complete follow-up with participants. If the recruitment goal is met and 80% compliance with study visit attendance is achieved, the trial will be classified as feasible (yes/no classification).

  This will be assessed at the completion of the study, approximately 1-1.5 years after the study start.

Secondary Outcomes (7)

• Change in Physical Function

  Pre- Program, Immediately Post-Program, and 1 Month Follow Up

• Change in Anxiety

  Pre- Program, Immediately Post-Program, and 1 Month Follow Up

• Change in Depression

  Pre- Program, Immediately Post-Program, and 1 Month Follow Up

• Change in Fatigue

  Pre- Program, Immediately Post-Program, and 1 Month Follow Up

• Change in Sleep Disturbance

  Pre- Program, Immediately Post-Program, and 1 Month Follow Up

Study Arms (1)

Self-induced therapeutic tremor (SITT) combined with mindfulness

EXPERIMENTAL

This arm will consist of self-induced therapeutic tremor (SITT) training combined with mindfulness training that is performed during a 60 minute session, 2 times per week, for 4 weeks. Self-induced therapeutic tremor (SITT) combined with mindfulness: SITT is a way to reduce stress by turning on a natural shaking response. This can calm the participant's body. It involves doing simple exercises. During SITT muscles will gently shake, and release built up stress. This shaking of muscles lets the participant's body physically let go of tension and stress. Mindfulness is the ability to be fully present in a moment so that the participant can focus on what the participant is sensing and feeling in the moment. It involves the acceptance of thoughts and feelings without judging them. Practicing mindfulness involves breathing methods, guided imagery, and other practices to relax the body and mind, help reduce stress, and not be overwhelmed.

Behavioral: Self-induced therapeutic tremor (SITT) combined with mindfulness

Interventions

Self-induced therapeutic tremor (SITT) combined with mindfulness BEHAVIORAL

SITT is a way to reduce stress by turning on a natural shaking response. This can calm the participant's body. It involves doing simple exercises. The muscles will gently shake, and release built up stress. This shaking of the muscles lets the participant's body physically let go of tension and stress. Mindfulness is the ability to be fully present in a moment. This allows focus on what the participant is sensing and feeling in the moment. It involves the acceptance of thoughts and feelings without judging them. Practicing mindfulness involves breathing methods, guided imagery, and other practices to relax the body and mind, help reduce stress, and not be overwhelmed by what's going on around the participant.

Self-induced therapeutic tremor (SITT) combined with mindfulness

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• Age \>18
• Physical requirements: be able to complete the intervention sessions
• Not seeking other therapeutic modalities, such as acupuncture, PT, during study duration
• Free from surgery for \>3 months
• being treated clinically for chronic pelvic pain and related conditions
• CPP of 6 months or more (to be considered chronic)
• Availability to commit to the 4-week intervention (two 60-minute sessions per week at a specified time, for 4 weeks)
• Internet access and consistent access to phone/email/text communication

You may not qualify if:

• Pregnancy
• Illicit substance use (e.g. cocaine, methamphetamines, heroin, street drugs) - marijuana and CBD oil and related supplements will be considered on a case-by-case basis by the principal investigators
• Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

The University of Tennessee Graduate School of Medicine

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Combined Alternative Therapy: The novel combined alternative therapy that will be studied consists of self-induced therapeutic tremors (SITT) plus mindfulness. SITT is the intentional induction of the body's innate tremor mechanism to treat hyperarousal and muscle tension, which is characteristic of CPP. SITTs are thought to restore somatic and autonomic nervous system homeostasis, by discharging sympathetic arousal and down-regulating the autonomic nervous system. Previous work has shown that mindfulness training may improve symptoms of CPP, however there are no studies investigating the impact that the combination of mindfulness coupled with SITTs may have on the symptoms of CPP.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: July 20, 2022
• Study Start: August 12, 2021
• Primary Completion: April 29, 2022
• Study Completion: May 30, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)