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

NCT ID: NCT03142477

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized into tree different groups: control, placebo, treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Questionnaires

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Questionnaires

Intervention Type 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.

Placebo therapeutic touch

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Questionnaires

Intervention Type 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.

Therapeutic touch

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Rubens Lene Carvalho Tavares

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubens Tavares, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

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Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rubens Tavares, MD, PhD

Role: CONTACT

5531 3409 9485

Gelza Nunes, MSc

Role: CONTACT

5531 3409 9485

Facility Contacts

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Rubens Tavares, MD,PhD

Role: primary

+5531 3409 9485

Gelza Nunes, MSc

Role: backup

+5531 3409 9485

Other Identifiers

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52649715.9.0000.5149

Identifier Type: -

Identifier Source: org_study_id

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