NCT04515381

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2018

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

11 days

First QC Date

August 6, 2020

Last Update Submit

August 14, 2020

Conditions

Keywords

Therapeutic touchDaytime sleepinessSleep qualityStressFatigueNurse-midwifery student

Outcome Measures

Primary Outcomes (4)

  • Change in Perceived Stress Scale

    The score of PSS-10 varied from 0 to 40. High score shows the excessiveness of the perceived stress of the individual

    Change from baseline and 4 weeks.

  • Change in Epworth Sleepiness Scale

    The scale consists of 8 items and score varies from 0-24. If the total score is between 2-10, it is considered as normal, pathological sleepiness indicator is greater than 10, thirteen and higher values are considered excessive daytime sleepiness.

    Change from baseline and 4 weeks.

  • Change in Pittsburgh Sleep Quality Index

    In PSQI analysis, 18 items were scored and there are 7 categories as in subjective sleep quality, delayed sleep, sleep duration, accustomed sleep activity, sleep disorder, use of sleeping pill and daytime dysfunction. Total score varies from 0 to 21. If the total PSQI score is ≤5, it stands for "good sleep quality", and if the score is \>5, it stands for "bad sleep quality"

    Change from baseline and 4 weeks.

  • Change in Visual Analogue Scale

    The scale of fatigue is a scale of 10 cm that assesses the severity of the fatigue in the last week. The left side of the scale contains the label of "I do not feel fatigue", while the right side of the scale contains the label of "I Feel Extreme Fatigue and Exhaustion". VASF value is determined through the measurement of the distance between the very left side of the scale and the marked point

    Change from baseline and 4 weeks.

Study Arms (3)

Therapeutic touch group

EXPERIMENTAL

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

Other: Therapeutic Touch

Placebo group

PLACEBO COMPARATOR

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.

Other: Sham Therapeutic Touch

Control group

OTHER

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

Other: Control group

Interventions

Therapeutic Touch

Therapeutic touch group

Making measurements at the beginning of the research and 4 weeks

Control group

Sham Therapeutic Touch

Placebo group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Artuklu University

Mardin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FatigueSleepinessDisorders of Excessive SomnolenceSleep Initiation and Maintenance Disorders

Interventions

Therapeutic TouchControl Groups

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 17, 2020

Study Start

April 20, 2018

Primary Completion

May 1, 2018

Study Completion

June 15, 2018

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations