Mindfulness Yoga and Sexual Functioning

NCT05461534 | Unknown

• 1 other identifier: CTR20220630
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Sexual Dysfunction

Outcome Measures

Primary Outcomes (3)

• Change from sexual activity

  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

  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

  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 Outcomes (6)

• Change from 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

  4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention

• Change from 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

  4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention

• Change from Sleep quality

  4 weeks (T1), 8 weeks (T2);three months (T3) and six months (T4) after completion of the 8 weeks intervention

Study Arms (2)

Intervention group: mindfulness yoga

EXPERIMENTAL

an 8-week structured mindfulness yoga program

Behavioral: mindfulness yoga

Waiting-list control group

NO INTERVENTION

provided the 8-week structured mindfulness yoga upon their completion of the study

Interventions

mindfulness yoga BEHAVIORAL

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).

Intervention group: mindfulness yoga

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

Location

Related Publications (1)

• Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.

  PMID: 40421669 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 18, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

CN (1)