Effects of Therapeutic Touch in Patients With Female Genital Neoplasia: a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Quality of life
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control
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.
Intervention: Questionnaires (Other)
Placebo
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.
Intervention: Questionnaires (Other)
Placebo
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.
Intervention: Placebo therapeutic touch (Other)
Treatment
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.
Intervention: Questionnaires (Other)
Treatment
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.
Intervention: Therapeutic touch (Other)
Outcomes
Primary Outcomes
Quality of life
Time Frame: up to 16 weeks of follow-up
Quality of life questionnaire WHOQOL-Bref
Secondary Outcomes
- Quality of life 2(up to 16 weeks of follow-up)
- Salivary cortisol(Between 10 to 16 weeks)
- Telomerase activity(up to 16 weeks of follow-up)
Investigators
Rubens Lene Carvalho Tavares
Professor
Federal University of Minas Gerais