CClinicalTrials.gg
Status unknownNCT03142477Updated May 5, 2017

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

An interventional study of Questionnaires and Placebo therapeutic touch in Quality of Life, Gynecologic Neoplasm and Gynecologic Cancer, sponsored by Federal University of Minas Gerais. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-05.

Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Aug 2016, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Therapeutic touch
  • Reiki
  • Laying-on-of-Hands
  • Spiritual Therapies
03

In context

Genital Neoplasms, Female

117 studies on the registry are indexed under Genital Neoplasms, Female; 19 are open to participants now.

This study's planned enrollment of 90 is close to the median of 90 across 92 interventional studies indexed under Genital Neoplasms, Female.

Browse Genital Neoplasms, Female studies →

Lead sponsor

Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Other
    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.

    Other: Questionnaires

  • Placebo comparator
    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.

    Other: Questionnaires · Other: Placebo therapeutic touch

  • Experimental
    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.

    Other: Questionnaires · Other: Therapeutic touch

Interventions

  • OtherQuestionnaires

    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.

  • OtherPlacebo 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.

  • OtherTherapeutic 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.

06

What researchers measure

Primary outcomes

  1. Quality of life

    Quality of life questionnaire WHOQOL-Bref

    Time frame: up to 16 weeks of follow-up

Secondary outcomes

  1. Salivary cortisol

    Salivary cortisol will be measured after the use of therapeutic touch

    Time frame: Between 10 to 16 weeks

  2. Quality of life 2

    Quality of life questionnaire EORTC QLQ-C30

    Time frame: up to 16 weeks of follow-up

  3. Telomerase activity

    Telomerase activity will be measured after the use of therapeutic touch

    Time frame: up to 16 weeks of follow-up

07

Study locations

1 of 1 sites recruiting
  • Federal University of Minas Gerais
    Belo Horizonte, Minas Gerais 30130-100, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03142477
Lead sponsor
Federal University of Minas Gerais
Responsible party
Rubens Lene Carvalho Tavares (Professor, Federal University of Minas Gerais) — Principal investigator
First posted
May 5, 2017
Start date
Aug 1, 2016
Primary completion
Jul 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
May 5, 2017

Study contacts

Rubens Tavares, MD, PhD
Contact
rubens.ufmg@gmail.com
5531 3409 9485
Gelza Nunes, MSc
Contact
nunesgelza@gmail.com
5531 3409 9485
Rubens Tavares, MD, PhD
principal investigator · Federal University of Minas Gerais

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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