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Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study

NCT06057636 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-05-10

No results posted yet for this study

Summary

The purpose of this study is to compare two hypnotic interventions for Black women with advanced cancer pain in preparation for a well-powered phase III study. The investigators plan to enroll 30 adult Black women with advanced cancer pain in a 2-arm pilot randomized controlled trial (RCT).

The primary aim will be to evaluate the feasibility of conducting the 2-arm clinical trial. It is hypothesized that at least 75% of participants in both study arms will complete study requirements. The secondary aims will be to evaluate the participant's experience with the intervention and to determine the effect size of the intervention on pain severity.

Conditions

  • Breast Cancer
  • Inflammatory Breast Cancer Stage IV
  • Inflammatory Breast Neoplasms
  • Triple Negative Breast Neoplasms
  • Neoplasm Metastasis

Interventions

BEHAVIORAL

Self-Administered Hypnosis

Participants will choose from one of three 20-minute prerecorded hypnosis audio files. Practices using the recordings will be documented on the hypnosis practice log.

BEHAVIORAL

Self-Administered White Noise Hypnosis

Participants will be listening to the same 20-minute white noise audio recording for 6 weeks and will be encouraged to practice daily. Practices using the recordings will be documented on the hypnosis practice log.

Sponsors & Collaborators

  • Baylor University

    collaborator OTHER

  • The University of Tennessee, Knoxville

    lead OTHER

Principal Investigators

  • Noel M Arring, DNP, PhD, RN · University of Tennessee Knoxville

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-08
Primary Completion
2024-05-08
Completion
2024-05-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06057636 on ClinicalTrials.gov