Cukurova University Faculty of Medicine Non-interventional Clinical Research Institutional Ethics Committe

March 14, 2023 updated by: Ozlem Yalcinkaya, Cukurova University

the Effect of Therapeutic Touch on Sleep Quality and Fatigue in Menopausal Women

This research was carried out to determine the effect of therapeutic touch on sleep quality and fatigue in menopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: This randomized controlled experimental study was conducted with 48 (24 in the intervention group and 24 in the control group) women who sought treatment in the gynecological outpatient clinic of a public hospital. According to the study procedure, while the intervention group received therapeutic touch, the control group received SHAM therapeutic touch for 10 minutes a day for five consecutive days. Data were collected through the Personal Information Form, the Pittsburgh Sleep Quality Index, and the Piper Fatigue Scale.

Results: The median post-test total sleep quality score was significantly lower in the intervention group than in the control group (p=0.010). However, the mean total fatigue scores did not differ significantly between the groups (p=0.917).

Conclusions: The results of this study showed that therapeutic touch was effective in improving sleep quality, but it did not affect fatigue in menopausal women.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Saricam
      • Adana, Saricam, Turkey, 01330
        • Ozlem Yalcinkaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

The study included women who agreed to participate in the study, lived in the city center, were at least literate, were in the natural premenopausal (irregular menstrual cycle within the last three months), perimenopausal (amenorrhea for 3-11 months or increased irregular menstruation), or postmenopausal (amenorrhea for more than 12 months) periods, were open to communication and cooperation, and could speak Turkish.

Exclusion Criteria:

The women who received hormone replacement treatment, used drugs for sleep problems and depression, were diagnosed with a medical psychiatric disease, and had sensitivity or problems about touching were excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experiment
Therapeutic touch (TT) is a treatment that takes an average of 15-20 min, in which energy in the universe is transferred through the hands of the practitioner to eliminate the imbalance in the individual's energy field and facilitate healing. The intervention group (TT group) received therapeutic touch for 10 minutes a day for five consecutive days. The practice was implemented in line with Therapeutic Practice Procedure.
Behavioral: Therapeutic Touch
Therapeutic Touch performed in line with the Therapeutic Touch Practice Procedure included the following steps: centering, assessing, rebalancing, reassessing, reexamining, grounding, and closure.
Sham Comparator: Control
Placebo: Sham Therapeutic Touch (STT) The control group was administered STT instead of TT for 10 minutes for successive 5 days. The practice was implemented in line with Sham Therapeutic Touch Practice Procedure (STTPP).
Other: Sham Therapeutic Touch
The control group was administered STT instead of TT for 10 minutes for successive 5 days. The practice was implemented in line with STTPP. The practice was implemented by not centering or intending to help to heal, by moving at a longer distance, and by imitating the TT practice protocol visually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: 9 months
The Turkish version of the Pittsburgh Sleep Quality Index (PSQI), which was developed by Buyssee et al. (1989), was used for the assessment of sleep quality. It is a self-report scale that makes a quantitative assessment of sleep quality and sleep disorders over a one-month time interval [30]. Turkish reliability and validity of the scale were performed by Ağargün et al. in our country (1996) [31]. The scale is composed of 18 items and seven sub-scales, which include Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorders, Use of Sleeping Drugs, and Daytime Dysfunction. Each item is scored between 0 and 3. The total score of the seven sub-scales gives the PSQI score. Scores to be obtained from the scale range between 0 and 21. A total score greater than 5 indicates "poor sleep quality." Cronbach's alpha reliability coefficient of the PSQI was reported 0,804 in the Turkish adaptation of the scale [31].
9 months
Fatigue
Time Frame: 9 months
The Turkish version of the Piper Fatigue Scale (PFS) was utilized to assess fatigue. PFS was developed by Barbara F. Piper et al. in 1987 [32]. Turkish reliability and validity of the scale were performed by Can et al. (2001) [33]. The scale responded on a 5-point Likert scale has 22 items and four sub-scales and it aims to assess individuals' subjective perceptions about fatigue. The sub-scales are Behavioral/Severity, Affective Meaning, Sensory, and Cognitive /Mood. Calculation of the sub-scale scores is done by summing all the items in that sub-scale and dividing it by the number of items. Higher scores indicate higher fatigue levels. Total Cronbach's alpha value was reported to be 0,99 in the Turkish reliability and validity of the scale [33].
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Study Chair: Ebru GOZUYESIL, PhD, Cukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.07.2021/46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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