Effects of Therapeutic Touch in Patients With Female Genital Neoplasia: a Randomized Controlled Clinical Trial

Not Applicable

• Conditions: Quality of Life; Gynecologic Neoplasm; Reiki; Gynecologic Cancer; Palliative Care; Therapeutic Touch
• Interventions: Other: Questionnaires; Other: Placebo therapeutic touch; Other: Therapeutic touch

• Registration Number: NCT03142477
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

This is a randomized controlled prospective study on the use of therapeutic touch in patients diagnosed with gynecological cancer. The patients will be randomized into three groups: control group (will not receive any interventions with therapeutic touch), placebo group (will receive simulated therapeutic touch intervention by individual not knowing this technique) and treatment group(will receive therapeutic touch intervention by a trained therapeutic touch therapist). Two different quality of life questionnaires will be applied (before and after treatment). Levels of cortisol, salivary IgA, hematological indices and telomerase activity before and after the use of therapeutic touch will be compared between groups.

Detailed Description

This project is a randomized controlled prospective study on the use of therapeutic touch in patients diagnosed with gynecological cancer. The patients will be randomized into three groups: control group (will not receive any interventions with therapeutic touch), placebo group (will receive simulated therapeutic touch intervention by individual not knowing the practice) and treatment group (will receive therapeutic touch intervention by a trained therapeutic touch therapist). Two different quality of life questionnaires (World Health Organization quality of life questionnaire - WHOQOL-Bref and the quality of life Core-30 questionnaire - EORTC QLQ-C30) from the European Organization for Research and Treatment of Cancer will be applied before and after treatment. Levels of cortisol, salivary IgA, hematological indices and telomerase activity before and after the use of therapeutic touch will be compared between groups.

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-04
• Last Update Submitted: 2017-05-04
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05
• Primary Completion: 2018-07-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• female patients
• age over 18 years
• diagnosis of neoplasms of the female genitalia
• Signature of the consent form

Exclusion Criteria

• history of previous contact with the therapeutic touch technique
• use of psychotropic drugs, severe neurological or psychiatric disorders that make it impossible to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Questionnaires	Control group patients will not receive any interventions with therapeutic touch. Two different quality of life questionnaires (WHOQOL-Bref and EORTC QLQ-C30) will be applied before and after treatment. Levels of cortisol, salivary IgA, hematological index results and telomerase activity before and after the use of therapeutic touch will be measured.
Placebo	Placebo therapeutic touch	Placebo patients group patients will receive the therapeutic touch intervention by a graduate student without any therapeutic touch training. Two different quality of life questionnaires (WHOQOL-Bref and EORTC QLQ-C30) will be applied before and after treatment. Levels of cortisol, salivary IgA, hematological index results and telomerase activity before and after the use of therapeutic touch will be measured.
Placebo	Questionnaires	Placebo patients group patients will receive the therapeutic touch intervention by a graduate student without any therapeutic touch training. Two different quality of life questionnaires (WHOQOL-Bref and EORTC QLQ-C30) will be applied before and after treatment. Levels of cortisol, salivary IgA, hematological index results and telomerase activity before and after the use of therapeutic touch will be measured.
Treatment	Questionnaires	Treatment patients group patients will receive the therapeutic touch interventions with a trained therapeutic touch professional. Two different quality of life questionnaires (WHOQOL-Bref and EORTC QLQ-C30) will be applied before and after treatment. Levels of cortisol, salivary IgA, hematological index results and telomerase activity before and after the use of therapeutic touch will be measured.
Treatment	Therapeutic touch	Treatment patients group patients will receive the therapeutic touch interventions with a trained therapeutic touch professional. Two different quality of life questionnaires (WHOQOL-Bref and EORTC QLQ-C30) will be applied before and after treatment. Levels of cortisol, salivary IgA, hematological index results and telomerase activity before and after the use of therapeutic touch will be measured.

Primary Outcome Measures

Name	Time	Method
Quality of life	up to 16 weeks of follow-up	Quality of life questionnaire WHOQOL-Bref

Secondary Outcome Measures

Name	Time	Method
Salivary cortisol	Between 10 to 16 weeks	Salivary cortisol will be measured after the use of therapeutic touch
Quality of life 2	up to 16 weeks of follow-up	Quality of life questionnaire EORTC QLQ-C30
Telomerase activity	up to 16 weeks of follow-up	Telomerase activity will be measured after the use of therapeutic touch

Trial Locations

Locations (1)

Federal University of Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil