Title: Effect of Therapeutic Touch on Daytime Sleepiness, Stress and Fatigue

NCT ID: NCT04515381

Last Updated: 2020-08-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-20

Study Completion Date

2018-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Objective: This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery.

Design: Randomized placebo-controlled study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The trial was conducted between April and July 2018. The students who met the inclusion criteria were separated into three groups through randomization method as in therapeutic touch (n=32), placebo (n=32) and control (n=32), and a total of 96 students participated in the study. In this randomized placebo controlled study, the therapeutic touch group were subjected to therapeutic touch for twice a week throughout 4 weeks with each session of 20 minutes. The data was acquired via Student Information Form, Epworth Sleepiness Scale, Pittburgh Sleep Quality Index, Perceived Stress Scale and Visual Analogue Scale for Fatigue.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Fatigue Sleepiness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Therapeutic touch group

Each student from the Therapeutic touch (TT) group was given TT sessions via Krieger-Kunz method in a total of 8 times in the manner of twice a week for one group (Monday - Wednesday) and another group (Tuesday - Thursday) for a duration of 1 month (4 week). TT application procedure: The procedure was explained to the student, the student person was concentrated, concentrated practitioner for TT application, the student's entire body was evaluated from head to foot with the practitioner's hands at a distance of about 2 inc, hands were moved regularly and rhythmically to prevent imbalances in the energy field, the energy field was re-evaluated from top to bottom and rebalanced if there was a blocked area, finally, the student was left to rest and response to the treatment was observed. The TT sessions of 20 minutes were applied on the students and they were given a short rest at the end of the session

Group Type EXPERIMENTAL

Therapeutic Touch

Intervention Type OTHER

Therapeutic Touch

Placebo group

For students in the placebo group, the similar duration (20 minutes) and frequency (2 sessions a week, total of 8 sessions) of TT was applied with hands at a certain distance from the body (approximately 5 cm) and they were moved without a specific order. The application was performed by the other researcher in a separate room to the placebo group.

Group Type PLACEBO_COMPARATOR

Sham Therapeutic Touch

Intervention Type OTHER

Sham Therapeutic Touch

Control group

There was no attempt being made towards the students within the control group. At the end of the 4th week, all students were asked to repeat measurements

Group Type OTHER

Control group

Intervention Type OTHER

Making measurements at the beginning of the research and 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Therapeutic Touch

Therapeutic Touch

Intervention Type OTHER

Control group

Making measurements at the beginning of the research and 4 weeks

Intervention Type OTHER

Sham Therapeutic Touch

Sham Therapeutic Touch

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* students who were at and above the age of 18,
* were the 1st year, 2nd year, 3rd year or 4th year students of nursing or midwifery,
* did not receive any energy therapy (Reiki, healing touch, therapeutic touch),
* received a score above 10 from the Epworth sleepiness scale (ESS),
* did not have any communication problem,
* and accepted to take part in the study were included in the study.

Exclusion Criteria

* Students who were getting a psychologic and/or pharmacologic treatment in regard to their sleep, fatigue and stress problems,
* previously got a psychiatric diagnosis, still had a psychiatric illness,
* previously or still used anxiety (psychotropic) medicines were excluded from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mardin Artuklu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Birgül Vural Doğru

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mardin Artuklu University

Mardin, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MAU.SRP.SH.005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Art Therapy and Caregivers Stress
NCT06357078 COMPLETED NA