SleepNCT05635578
The Effect of Reiki Applicatıon on Sleep and Qualıty of Life in Epılepsy Patıents
A study testing sleep in people with Sleep and Life Quality, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
After the general period of positive social adjustments, epilepsy is in a high life cycle to control seizures. During seizures in epilepsy, patients' quality of life and antiepileptic life span can be seen in daily life such as daily life and daily awakenings. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Life Quality
- What is being tested?
- sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 1 May 2023
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- be over 18 years old
- Ability to communicate adequately
- Absence of psychiatric problems
- Not having received body-mind therapy (yoga, reiki, massage, meditation) in the last six months
- Volunteering to participate in the research
- Own a phone
- Having a scale score of greater than 5 according to the Pittsburgh Sleep Quality Scale
- Not using sleeping pills 4.4.2. Exclusion Criteria from Research
- being under the age of 18
- Having trouble communicating
- Having a psychiatric problem
- Having received body-mind therapy (yoga, reiki, massage, meditation) in the last six months
- Not being willing to participate in the research
- Not having a phone
- Having a scale score of less than and/or equal to 5 on the Pittsburgh Sleep Quality Scale
- Using sleeping pills
Trial locations and contacts
1 site in 1 country.
About this study
After the general period of positive social adjustments, epilepsy is in a high life cycle to control seizures. During seizures in epilepsy, patients' quality of life and antiepileptic life span can be seen in daily life such as daily life and daily awakenings.
Reiki, which has been proven by studies in health problems such as fatigue and pain; an energy that can be unblocked or applied in a non-applicable way can benefit from a therapy that can be applied by touch or remotely, without negative effects. In the literature, reiki applied to epilepsy patients has sleep and quality of life. This thesis is planned to do research on sleep and living areas of reiki applied to epilepsy patients.
Read the detailed description
This research; It will be carried out on a voluntary basis with the treatment of 60 patients with epilepsy, 30 of which will be tested, 30 of which will be comprehensive, from the University of Fır Hospital Neurology Clinic Polyclinic and those over 18 years of age, who can communicate adequately, who have psychiatric problems, who are in the last six body mind, who can control the phone, who will come to the scale, who will come to sleep. The study will be a pretest-posttest controlled group study. Data; Patient Information Form will be collected with Pittsburgh Sleep Quality Scale, Quality of Life in Epilepsy Scale. The control method will not interfere. If we try, first the application places and the way of doing it will be shown. Administration through 4 weeks, first consecutive week; 1 session face-to-face 30-45 minutes, then 3 sessions of 21 minutes of training, 2 sessions of 21 minutes of training in the other 3 training courses, a total of 4 weeks 10. For face-to-face reiki; A room will be used inside the hospital. Reiki to 7 different chakras to be taken in the first session. For the other sessions, before the application, all will be called and informed about the reiki will be sent, and then he will apply reiki from a distance for 21 minutes by using the training and reiki symbols. The scales will be reapplied by the researcher, either face to face or face to face, during the experiment and 4 weekends to be controlled. Finally, there will be a significant difference between the pretest and the son test.
- Conditions
- Sleep, Life Quality
- Being tested
- sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleepBehavioural
Also called life quality
reiki
| Study group | Role | What they receive |
|---|---|---|
| Experimental: | Experimental | reiki will be aplicated Receives: Behavioral: sleep |
| Control | No intervention | Routine maintenance will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
The Pitssburgh sleep quality index, developed by Buysse et al. in 1989, is used to evaluate the quality of sleep, the amount of sleep, the presence and severity of sleep disorders in the last month. Agargun et al. They adapted PUKI to Turkish in 1996.There are seven components in the scale. These; subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6) and daytime dysfunction (component 3) 7) stop. The evaluation score of each item is between 0-3, and the total score obtained at the end of the evaluation is between 0-21. A total score of 5 and less than 5 defines good sleep, and a total score of more than 5 defines poor sleep
Measured: 1 hours later
Quality of Life Scale in Epilepsy
The Quality of Life Scale for Patients with Epilepsy was developed by Vickrey et al. in 1993. Mollaoğlu et al. carried out the validity and reliability studies of this scale in Turkey in 2015. The scale includes 7 sub-dimensions. These sub-dimensions are; anxiety about seizures (5 items), effects of drugs (3 items), energy/fatigue (4 items), emotional well-being (5 items), cognitive function (6 items), social function (5 items), total quality of life (2 items) ) and an additional item that evaluates the total health status, a total of 31 items. Scale scoring is in the range of 0-100. High score indicates higher quality of life
Measured: 1 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start15 Nov 2022
- Primary completion25 Feb 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- reiki
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gülcan bahcecioğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635578
- Sponsor's protocol ID
- 2022/30-34
- Status last verified
- Jun 2023
- First submitted
- 23 Nov 2022
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki Applicatıon on Sleep and Qualıty of Life in Epılepsy Patıents
- ClinicalTrials.gov ID
- NCT05635578
- Acronym / sponsor ID
- 2022/30-34
- Conditions
- Sleep, Life Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 2 Dec 2022 (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.
After the general period of positive social adjustments, epilepsy is in a high life cycle to control seizures. During seizures in epilepsy, patients' quality of life and antiepileptic life span can be seen in daily life such as daily life and daily awakenings.
Reiki, which has been proven by studies in health problems such as fatigue and pain; an energy that can be unblocked or applied in a non-applicable way can benefit from a therapy that can be applied by touch or remotely, without negative effects. In the literature, reiki applied to epilepsy patients has sleep and quality of life. This thesis is planned to do research on sleep and living areas of reiki applied to epilepsy patients.
Detailed description
This research; It will be carried out on a voluntary basis with the treatment of 60 patients with epilepsy, 30 of which will be tested, 30 of which will be comprehensive, from the University of Fır Hospital Neurology Clinic Polyclinic and those over 18 years of age, who can communicate adequately, who have psychiatric problems, who are in the last six body mind, who can control the phone, who will come to the scale, who will come to sleep. The study will be a pretest-posttest controlled group study. Data; Patient Information Form will be collected with Pittsburgh Sleep Quality Scale, Quality of Life in Epilepsy Scale. The control method will not interfere. If we try, first the application places and the way of doing it will be shown. Administration through 4 weeks, first consecutive week; 1 session face-to-face 30-45 minutes, then 3 sessions of 21 minutes of training, 2 sessions of 21 minutes of training in the other 3 training courses, a total of 4 weeks 10. For face-to-face reiki; A room will be used inside the hospital. Reiki to 7 different chakras to be taken in the first session. For the other sessions, before the application, all will be called and informed about the reiki will be sent, and then he will apply reiki from a distance for 21 minutes by using the training and reiki symbols. The scales will be reapplied by the researcher, either face to face or face to face, during the experiment and 4 weekends to be controlled. Finally, there will be a significant difference between the pretest and the son test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- reiki
| Arm | Type | Receives |
|---|---|---|
| Experimental: | Experimental | Behavioral: sleepreiki will be aplicated |
| Control | No intervention | –Routine maintenance will be applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| sleepAlso: life qualityreiki | Behavioural | Experimental: |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 1 hours later
The Pitssburgh sleep quality index, developed by Buysse et al. in 1989, is used to evaluate the quality of sleep, the amount of sleep, the presence and severity of sleep disorders in the last month. Agargun et al. They adapted PUKI to Turkish in 1996.There are seven components in the scale. These; subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6) and daytime dysfunction (component 3) 7) stop. The evaluation score of each item is between 0-3, and the total score obtained at the end of the evaluation is between 0-21. A total score of 5 and less than 5 defines good sleep, and a total score of more than 5 defines poor sleep
Quality of Life Scale in Epilepsy
Time frame: 1 hours later
The Quality of Life Scale for Patients with Epilepsy was developed by Vickrey et al. in 1993. Mollaoğlu et al. carried out the validity and reliability studies of this scale in Turkey in 2015. The scale includes 7 sub-dimensions. These sub-dimensions are; anxiety about seizures (5 items), effects of drugs (3 items), energy/fatigue (4 items), emotional well-being (5 items), cognitive function (6 items), social function (5 items), total quality of life (2 items) ) and an additional item that evaluates the total health status, a total of 31 items. Scale scoring is in the range of 0-100. High score indicates higher quality of life
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 8 Jun 2023.
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Healthy Adult Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep in people with Sleep and Life Quality, run by Ataturk 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?
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 8 Jun 2023. 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?
Pittsburgh Sleep Quality Index (time frame: 1 hours later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2023.