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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2022-03-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Menopause Sleep Fatigue Therapeutic Touch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was conducted as a parallel randomized-controlled, single-blind, single-centered, interventional study with a pre-test and post-test design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Therapeutic Touch

Intervention Type BEHAVIORAL

Therapeutic Touch performed in line with the Therapeutic Touch Practice Procedure included the following steps: centering, assessing, rebalancing, reassessing, reexamining, grounding, and closure.

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).

Group Type SHAM_COMPARATOR

Sham Therapeutic Touch

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes