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

NCT03142477 | Unknown DMC

• 1 other identifier: 52649715.9.0000.5149
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Gynecologic Neoplasm; Gynecologic Cancer; Palliative Care; Therapeutic Touch; Reiki

Keywords

Therapeutic touch; Reiki; Laying-on-of-Hands; Spiritual Therapies

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Quality of life questionnaire WHOQOL-Bref

  up to 16 weeks of follow-up

Secondary Outcomes (3)

• Salivary cortisol

  Between 10 to 16 weeks

• Quality of life 2

  up to 16 weeks of follow-up

• Telomerase activity

  up to 16 weeks of follow-up

Study Arms (3)

Control

OTHER

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.

Other: Questionnaires

Placebo

PLACEBO COMPARATOR

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.

Other: Questionnaires; Other: Placebo therapeutic touch

Treatment

EXPERIMENTAL

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.

Other: Questionnaires; Other: Therapeutic touch

Interventions

Questionnaires OTHER

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.

Control; Placebo; Treatment

Placebo therapeutic touch OTHER

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.

Placebo

Therapeutic touch OTHER

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: eligibility is based on self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

MeSH Terms

Conditions

Genital Neoplasms, Female

Interventions

Surveys and Questionnaires; Therapeutic Touch

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Rubens Tavares, MD, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubens Tavares, MD, PhD

CONTACT

5531 3409 9485; rubens.ufmg@gmail.com

Gelza Nunes, MSc

CONTACT

5531 3409 9485; nunesgelza@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized into tree different groups: control, placebo, treatment.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 5, 2017
• Study Start: August 1, 2016
• Primary Completion: July 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)