COPDNCT04842903
Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease
A study testing Therapeutic Touch in people with COPD and Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Therapeutic Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2018to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal Univercity
Bolu, 14030
About this study
Official title: Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
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.
- Being tested
- Therapeutic Touch
- Keywords
- Chronic obstructive pulmonary disease, Therapeutic touch, Sleep quality, Anxiety
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Therapeutic touch and standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied. Receives: Other: Therapeutic Touch |
| Control Group | No intervention | Only standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (1)
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start15 Mar 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Çalışkan, Abant Izzet Baysal University
- Investigators
- Birgül CERİT, PhD, Study director, Bolu Abant Izzet Baysal University Faculty of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842903
- Sponsor's protocol ID
- AIBU-SBF-MAC-01
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34536666
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Touch on Sleep Quality and Anxiety in Individuals With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04842903
- Acronym / sponsor ID
- AIBU-SBF-MAC-01
- Keywords
- Chronic obstructive pulmonary disease, Therapeutic touch, Sleep quality, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Therapeutic TouchTherapeutic touch and standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied. |
| Control Group | No intervention | –Only standard nursing care of the clinic (such as breathing exercise, postural drainage) was applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic TouchTherapeutic 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. | Other | Experimental Group |
Primary outcome
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.
1 secondary outcome
State Anxiety Inventory
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Derived from this study: PubMed 34536666Caliskan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgül CERİT, PhD study director
Bolu Abant Izzet Baysal University Faculty of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch in people with COPD and Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richard-Campbell Sleep Questionnaire (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04842903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.