NCT04842903

Brief Summary

Purpose: The purpose is to determine the effect of therapeutic touch on the sleep quality and anxiety of individuals with chronic obstructive pulmonary disease. Material and methods: This study was conducted between March 2018 and March 2019 as a randomized controlled experimental study conducted with pre-test post-test model. In addition to the routine nursing care, therapeutic touch (TT) and study scales were applied to the experimental group for a total of three sessions, once a day and 10 minutes each, for three consecutive days and only study scales were applied to the control group. The data was collected using Personal Information Form, Richard-Campbell Sleep Questionnaire and State Anxiety Inventory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 5, 2021

Last Update Submit

April 8, 2021

Conditions

Keywords

Chronic obstructive pulmonary diseaseTherapeutic touchSleep qualityAnxiety

Outcome Measures

Primary Outcomes (1)

  • Richard-Campbell Sleep Questionnaire

    It was developed by Richards in 1987. It is a five-item scale that evaluates depth of night sleep, duration of falling asleep, frequency of awakening, duration of being awake when waking up and sleep quality. Each item in the scale is evaluated on a chart between 0 and 100 with visual analogue scale. The minimum score that can be obtained from the scale is 100, and the minimum score is 0. The higher the score on the scale, the higher the sleep quality. The Cronbach alpha coefficient of the scale, developed by Richards was 0.82.

    3 days

Secondary Outcomes (1)

  • State Anxiety Inventory

    3 days

Study Arms (2)

Experimental Group

EXPERIMENTAL

Therapeutic touch and standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied.

Other: Therapeutic Touch

Control Group

NO INTERVENTION

Only standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied.

Interventions

Therapeutic touch is an energy transfer process based on the assumption that every living organism in the universe has an energy field and these energy fields that interact with each other can be changed with the practices made by a conscious and certain intent. TT is an independent nursing practice first applied and developed by nurses Dora Kunz and Dolores Krieger in 1972. TT is also an art of concentration therapy in which the therapist focuses on consciousness as a focus to create balance and coordination in the mutual energy fields of the patient and the environment, and uses their hands to transfer energy. The fact that TT is easy to use, has no known side effects, has low costs, is non-invasive, and its importance among nurses and increasing frequency of its practice in recent years show that it is a powerful alternative to other CAT methods.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over the age of 18
  • Literate
  • Oriented, open to communication and cooperation
  • Those who are hospitalized in the clinic for at least four days
  • Patients who volunteered to participate in the study were included.

You may not qualify if:

  • Have any diagnosed psychiatric disorder
  • Using antidepressants, antihistamines, benzodiazepines, hypnotic and narcotic drugs
  • Persons using any other complementary and alternative treatment method during the therapeutic touch application were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal Univercity

Bolu, 14030, Turkey (Türkiye)

Location

Related Publications (1)

  • Caliskan MA, Cerit B. Effect of therapeutic touch on sleep quality and anxiety in individuals with chronic obstructive pulmonary disease: A randomized controlled trial. Complement Ther Clin Pract. 2021 Nov;45:101481. doi: 10.1016/j.ctcp.2021.101481. Epub 2021 Sep 8.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAnxiety DisordersSleep Initiation and Maintenance Disorders

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Birgül CERİT, PhD

    Bolu Abant Izzet Baysal University Faculty of Health Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 13, 2021

Study Start

March 15, 2018

Primary Completion

March 15, 2019

Study Completion

March 15, 2019

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations