Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04842903
Recruitment Status : Completed
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Mehmet Ali Çalışkan, Abant Izzet Baysal University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
COPD Anxiety Sleep Other: Therapeutic Touch Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Actual Study Start Date : March 15, 2018
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Experimental Group
Therapeutic touch and standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied.
 Other: Therapeutic Touch
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.
No Intervention: Control Group
Only standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Richard-Campbell Sleep Questionnaire [ Time Frame: 3 days ]
    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.


Secondary Outcome Measures :
  1. State Anxiety Inventory [ Time Frame: 3 days ]
    It was developed by Spielberger et al in 1970. State anxiety inventory measures the anxiety levels of individuals aged 14 years. The scale consists of 20 items. In the scale, participants are asked to mark one of the options "never = 1", "a little = 2", "a lot = 3", "totally = 4" according to the severity of the emotions, thoughts or behaviors they express. The highest score that can be obtained from the scale is 80 and the lowest score is 20. The higher the total scale score, the higher the anxiety level of the individual filling the scale. Spielberger et al. Stated that 0-19 points obtained from the scale are not anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-80 points mean severe anxiety, individuals with a score of 60 and above need professional help.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842903


Locations
Layout table for location information
Turkey
Bolu Abant Izzet Baysal Univercity
Bolu, Turkey, 14030
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
Layout table for investigator information
Study Director: Birgül CERİT, PhD Bolu Abant Izzet Baysal University Faculty of Health Science
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Mehmet Ali Çalışkan, Research Assisstant, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT04842903    
Other Study ID Numbers: AIBU-SBF-MAC-01
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Ali Çalışkan, Abant Izzet Baysal University:
Chronic obstructive pulmonary disease
Therapeutic touch
Sleep quality
Anxiety
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
 Anxiety Disorders
Mental Disorders
Respiratory Tract Diseases