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

Çukurova University

Status: Completed

Conditions: Therapeutic Touch; Menopause; Fatigue; Sleep

Treatments: Other: Sham Therapeutic Touch; Behavioral: Therapeutic Touch

Study type: Interventional

Funder types: Other

Identifiers

NCT05075694

09.07.2021/46

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Experiment

Experimental group

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.

Treatment:

Behavioral: Therapeutic Touch

Control

Sham Comparator group

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).

Treatment:

Other: Sham Therapeutic Touch