Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD, Anxiety, Sleep
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic Touch
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring Chronic obstructive pulmonary disease, Therapeutic touch, Sleep quality, Anxiety
Eligibility 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.
Sites / Locations
- Bolu Abant Izzet Baysal Univercity
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
Therapeutic touch and standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied.
Only standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
State Anxiety Inventory
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.
Full Information
NCT ID
NCT04842903
First Posted
April 5, 2021
Last Updated
April 8, 2021
Sponsor
Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT04842903
Brief Title
Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease
Official Title
Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Anxiety, Sleep
Keywords
Chronic obstructive pulmonary disease, Therapeutic touch, Sleep quality, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Therapeutic touch and standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Only standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied.
Intervention Type
Other
Intervention Name(s)
Therapeutic Touch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Richard-Campbell Sleep Questionnaire
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
State Anxiety Inventory
Description
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.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgül CERİT, PhD
Organizational Affiliation
Bolu Abant Izzet Baysal University Faculty of Health Science
Official's Role
Study Director
Facility Information:
Facility Name
Bolu Abant Izzet Baysal Univercity
City
Bolu
ZIP/Postal Code
14030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34536666
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease
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