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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03142477
• Other study ID #: 52649715.9.0000.5149
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2017
• Last updated: May 4, 2017
• Start date: August 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2017
• Source: Federal University of Minas Gerais
• Contact: Rubens Tavares, MD, PhD
• Phone: 5531 3409 9485
• Email: rubens.ufmg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Gynecologic Cancer
• Gynecologic Neoplasm
• Palliative Care
• Quality of Life
• Reiki
• Therapeutic Touch

Intervention

Other:
• Questionnaires
Two different quality of life questionnaires (WHOQOL-Bref and EORTC QLQ-C30) will be applied before and after treatment. No true or placebo therapeutic touch intervention will be performed.
• Placebo therapeutic touch
Placebo therapeutic touch will be done by graduate students without any specific training. The students are instructed to perform the placebo therapeutic touch with no objective intention of improving the patient's health.
• Therapeutic touch
Therapeutic touch will be done by therapeutic touch trained professionals graduate students without any specific training with the intention of improving the patient's health.

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of life questionnaire WHOQOL-Bref	up to 16 weeks of follow-up
Secondary	Salivary cortisol	Salivary cortisol will be measured after the use of therapeutic touch	Between 10 to 16 weeks
Secondary	Quality of life 2	Quality of life questionnaire EORTC QLQ-C30	up to 16 weeks of follow-up
Secondary	Telomerase activity	Telomerase activity will be measured after the use of therapeutic touch	up to 16 weeks of follow-up