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

Federal University of Minas Gerais

Status: Unknown

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

Treatments: Other: Placebo therapeutic touch; Other: Therapeutic touch; Other: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT03142477

52649715.9.0000.5149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups, including a placebo group

Control

Other group

Description:

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.

Treatment:

Other: Questionnaires

Placebo

Placebo Comparator group

Description:

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:

Other: Questionnaires

Other: Placebo therapeutic touch

Treatment

Experimental group

Description:

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:

Other: Therapeutic touch

Other: Questionnaires