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

NCT05075694 | Completed

• 1 other identifier: 09.07.2021/46
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menopause; Sleep; Fatigue; Therapeutic Touch

Keywords

Menopause; Sleep; Fatigue; Therapeutic touch

Outcome Measures

Primary Outcomes (2)

• 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 \[31\].

  9 months

• 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 \[33\].

  9 months

Study Arms (2)

Experiment

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Therapeutic Touch BEHAVIORAL

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

Experiment

Sham Therapeutic Touch 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.

Control

Eligibility Criteria

• Age: 45 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Ozlem Yalcinkaya

Adana, Saricam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Ebru GOZUYESIL, PhD

  Cukurova University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc Student

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

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 13, 2021
• Study Start: December 15, 2021
• Primary Completion: January 15, 2022
• Study Completion: March 15, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)