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

Primary Purpose

Menopause, Sleep, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic Touch
Sham Therapeutic Touch
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Menopause focused on measuring Menopause, Sleep, Fatigue, Therapeutic touch

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Residing in the city center,
  2. Least literate,
  3. Between the ages of 40-60,
  4. Those who are in natural premenopause (irregular menstrual cycle in the last three months), perimenopause (amenorrhea for 3-11 months or increasing irregular menstruation) or postmenopause (amenorrhea for more than 12 months),
  5. Having sleep and fatigue problems,
  6. Open to communication and cooperation,
  7. Able to understand and speak Turkish,
  8. Not taking hormone replacement therapy,
  9. Not using drugs for sleep problems and depression,
  10. Without a diagnosis of medical psychiatric disease,
  11. Volunteered to participate in the research

Exclusion Criteria:

  1. Sensitivity or problem with touch,
  2. Medical procedure for any reason during the intervention

Sites / Locations

  • Ozlem Yalcinkaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experiment

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Sleep Quality
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].
Fatigue
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].

Secondary Outcome Measures

Full Information

First Posted
September 16, 2021
Last Updated
March 14, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05075694
Brief Title
Cukurova University Faculty of Medicine Non-interventional Clinical Research Institutional Ethics Committe
Official Title
the Effect of Therapeutic Touch on Sleep Quality and Fatigue in Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Sleep, Fatigue, Therapeutic Touch
Keywords
Menopause, Sleep, Fatigue, Therapeutic touch

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was conducted as a parallel randomized-controlled, single-blind, single-centered, interventional study with a pre-test and post-test design
Masking
Participant
Masking Description
In this study, while the intervention group was administered Therapeutic Touch , the control group was administered Sham Therapeutic Touch (STT). The interventions in the study were implemented using the literature information as well as the Therapeutic Touch Practice Procedure (TTPP) and Sham Therapeutic Practice Procedure (STPP). To administer the TT practice, the researcher received a certificate by participating in the first and second-level courses held by the International Therapeutic Touch Association.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Touch
Intervention Description
Therapeutic Touch performed in line with the Therapeutic Touch Practice Procedure included the following steps: centering, assessing, rebalancing, reassessing, reexamining, grounding, and closure.
Intervention Type
Other
Intervention Name(s)
Sham Therapeutic Touch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep Quality
Description
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].
Time Frame
9 months
Title
Fatigue
Description
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].
Time Frame
9 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru GOZUYESIL, PhD
Organizational Affiliation
Cukurova University
Official's Role
Study Chair
Facility Information:
Facility Name
Ozlem Yalcinkaya
City
Adana
State/Province
Saricam
ZIP/Postal Code
01330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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