Clinical trial NCT03142477: Effects of Therapeutic Touch in Patients With Female Genital Neoplasia: a Randomized Controlled Clinical Trial
Official title: Effects of Therapeutic Touch in Patients With Female Genital Neoplasia: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Gynecologic Neoplasm
Gynecologic Cancer
Palliative Care
Therapeutic Touch
Reiki
Keywords: Therapeutic touch
Reiki
Laying-on-of-Hands
Spiritual Therapies
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into tree different groups: control, placebo, treatment.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life
timeFrame: up to 16 weeks of follow-up
Secondary outcomes:
measure: Salivary cortisol
timeFrame: Between 10 to 16 weeks
measure: Quality of life 2
timeFrame: up to 16 weeks of follow-up
measure: Telomerase activity
timeFrame: up to 16 weeks of follow-up
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Rubens Tavares, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: