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

Primary Purpose

Quality of Life, Gynecologic Neoplasm, Gynecologic Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Questionnaires
Placebo therapeutic touch
Therapeutic touch
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Therapeutic touch, Reiki, Laying-on-of-Hands, Spiritual Therapies

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Federal University of Minas GeraisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Placebo Comparator

Experimental

Arm Label

Control

Placebo

Treatment

Arm 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.

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 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.

Outcomes

Primary Outcome Measures

Quality of life
Quality of life questionnaire WHOQOL-Bref

Secondary Outcome Measures

Salivary cortisol
Salivary cortisol will be measured after the use of therapeutic touch
Quality of life 2
Quality of life questionnaire EORTC QLQ-C30
Telomerase activity
Telomerase activity will be measured after the use of therapeutic touch

Full Information

First Posted
May 2, 2017
Last Updated
May 4, 2017
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT03142477
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Gynecologic Neoplasm, Gynecologic Cancer, Palliative Care, Therapeutic Touch, Reiki
Keywords
Therapeutic touch, Reiki, Laying-on-of-Hands, Spiritual Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized into tree different groups: control, placebo, treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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
Intervention Name(s)
Placebo therapeutic touch
Intervention Description
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
Intervention Name(s)
Therapeutic touch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life
Description
Quality of life questionnaire WHOQOL-Bref
Time Frame
up to 16 weeks of follow-up
Secondary Outcome Measure Information:
Title
Salivary cortisol
Description
Salivary cortisol will be measured after the use of therapeutic touch
Time Frame
Between 10 to 16 weeks
Title
Quality of life 2
Description
Quality of life questionnaire EORTC QLQ-C30
Time Frame
up to 16 weeks of follow-up
Title
Telomerase activity
Description
Telomerase activity will be measured after the use of therapeutic touch
Time Frame
up to 16 weeks of follow-up

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
eligibility is based on self-representation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubens Tavares, MD, PhD
Phone
5531 3409 9485
Email
rubens.ufmg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gelza Nunes, MSc
Phone
5531 3409 9485
Email
nunesgelza@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens Tavares, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubens Tavares, MD,PhD
Phone
+5531 3409 9485
Email
rubens.ufmg@gmail.com
First Name & Middle Initial & Last Name & Degree
Gelza Nunes, MSc
Phone
+5531 3409 9485
Email
nunesgelza@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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