Mindfulness Yoga and Sexual Functioning

July 13, 2022 updated by: Rui Yan, The First Affiliated Hospital of Zhengzhou University

The Effect of Mindfulness Yoga on Sexual Functioning for Breast Cancer Survivors

Female breast cancer survivors with sexual dysfunction were randomly divided into a mindfulness yoga intervention group and a control group, and the investigators aimed to evaluate the effects of mindfulness yoga on sexual function in breast cancer survivors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Zhengzhou, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

age 18-65 years; diagnosed with primary breast cancer (stages:T1-T4, N0-N1, M0); individuals who have completed surgery, chemotherapy and radiotherapy (with the exception of immunotherapy and endocrine therapy); without cognitive impairment; diagnosed with sexual dysfunction.

Exclusion Criteria:

without sexual experience; in pregnancy or lactation; individuals with serious cognitive or psychiatric issues (i.e., depression, alcohol dependency, or psychotic disorders); individuals who are illiterate, with hearing disorder or communication difficulties; individuals with other type of tumors or other serious acute or chronic diseases at the time of enrollment; individuals participate in a concurrent medical treatment or nonmedical treatment targeting sexual problems; individuals participate in a concurrent psychotherapy; individuals with experience in mindfulness or yoga.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group: mindfulness yoga
an 8-week structured mindfulness yoga program
Behavioral: mindfulness yoga
Each mindfulness yoga session will last for 90 minutes and will be conducted in a group format once a week. Each session includes breathing exercise (10 min), mindfulness meditation and body scan (20 min) and yoga practice (60 min).
NO_INTERVENTION: Waiting-list control group
provided the 8-week structured mindfulness yoga upon their completion of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from sexual activity
Time Frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The score change of the Sexual Activity Questionnaire(SAQ).The SAQ consists of 10 items and three subscales. Higher pleasure or discomfort subscale score indicated higher levels of pleasure or discomfort, and habit is a single item (0 'less sexual activity than usual' to 3 'much more sexual activity than usual').
4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Female sexual function index
Time Frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The score change of Female Sexual Function Index (FSFI). FSFI consists of 19 items comprising six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain). The total score ranges from 0 to 36. Higher score corresponds to better sexual functioning.
4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Sexual distress
Time Frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The change of The Female Sexual Distress Scale-Revised (FSDS-R).The total score ranges from 0 to 48, and a higher score indicates a higher level of sexual distress.
4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Body Image
Time Frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Body Image Subscale (BIS) of the European Organization for Research and Treatment of Cancer Quality of Life-Breast Cancer Module (EORTC- QLQ-BR23) will be used. The total score ranges from 4 to 16, and higher score indicates higher level of body image.
4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Anxiety and Depression
Time Frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The Hospital Anxiety and Depression Scale (HADS) will be used.Higher HADS-D ( ranges from 0-21) or HADS-A ( ranges from 0-21) score correspond to more serious psychological distress
4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Menopausal symptoms
Time Frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The Endocrine symptom subscale (ESS) of the Endocrine Subscale for The Functional Assessment of Cancer Therapy-Breast (FACT-B ES) will be used. The total score ranges from 0 to 72. Higher score indicates fewer menopausal symptoms
4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Fatigue
Time Frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The Brief Fatigue Inventory (BFI) will be used. The total score ranges from 0 to 90. Higher scores on the BFI indicates greater self-reported levels of fatigue.
4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Sleep quality
Time Frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The Pittsburgh Sleep Quality Index (PSQI) will be used. The total score ranges from 0 to 21. Higher scores indicate poorer sleep quality.
4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
Change from Quality of life (QOL)
Time Frame: 4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) simplified Chinese V3.0 version will be used. The total score ranges from 0 to 100. Higher scores of symptom and financial scales indicates more severe symptoms.
4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2022

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2024

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (ACTUAL)

July 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTR20220630

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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