The effect of reflex therapy on late complications and sexual satisfaction of mastectomy patients

Phase 3

Recruiting

• Conditions: ate complications(such as lymphedema) and sexual satisfaction of mastectomy patients caused by breast cancer..; Postmastectomy lymphedema syndrome; I97.2

• Registration Number: IRCT20210525051406N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Willingness to participate in the study.
Married women with 30-60 years old who have sexual function.
Completion of all treatment methods, including: chemotherapy, radiotherapy or hormone therapy.
Having lymphedema at the beginning of the study.
Ability to answer the questions (not deaf mute).
Perform at least one breast surgery at 6-18 months ago.
Do not use of physiotherapy or mental counseling during the study.
Do not use of other methods of complementary medicine at the same time.
Do not have other type of malignancies during the study.
Having a fatigue intensity score equal to or greater than 36 on the whole scale, according to the FSS scale.
Having an anxiety score (8-14), stress score (15-25) and depression score (10-20) based on DASS-21 scale.
Having a sleep quality score equal to or greater than 5 based on the Petersburg Sleep Quality Scale.

Exclusion Criteria

Unwillingness of the participants to continue cooperation.
Use other methods of complementary medicine.
Having other malignancies at the same time.
Hospitalization.
Absence of more than 2 sessions.
Abuse of alcohol, drugs and other psychotropic substances.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ate complications of mastectomy patients. Timepoint: Pre-intervention, immediately after the end of the intervention, 1month after the end of the intervention. Method of measurement: Research variables are measured by several questionnaires including: demographic characteristics and fertility status, FSS, PSQI, DASS-21 questionnaires. Lymphedema is also measured with a meter from the patient's arm.

Secondary Outcome Measures

Name	Time	Method
Sexual satisfaction of mastectomy patients. Timepoint: Pre-intervention, immediately after the end of the intervention, 1month after the end of the intervention. Method of measurement: This variable is measured by the Sexual Satisfaction Scale (FSFI) questionnaire.