Sleep DisorderNCT05276635
Sleep Disorder Manage in Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy
A study testing The Sleep Hygiene Education (SHE) and Emotional Freedom Techniques (EFT) in people with Sleep Disorder and Sleep Disorder in Elderly, run by Matrouh University at 1 site in Egypt.
Trial summary
Sleep disorders are common among elderly persons, with deleterious effects on their physical and mental health. Many approaches are used to manage such disorders. Aim of the study: To compare the Emotional Freedom Techniques-Insomnia (EFT-I) and Sleep Hygiene Education (SHE) group therapy as two treatments for… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Sleep Disorder in Elderly, Sleep Disorder, Mental Health
- What is being tested?
- The Sleep Hygiene Education (SHE) and Emotional Freedom Techniques (EFT)
- 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 siteEgypt
- Study dates
- 3 Jan 2021to 31 Mar 2021
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients suffering insomnia sleep problem
- Age equal or more than 60 years
Who cannot join
- Those having major physical or psychiatric ailments or being on medication affecting their sleep were excluded
- These involved those history of epilepsy, seizures, or dementia, current alcohol or substance abuse/dependence (must have >90 days of sobriety), night shift workers, as well as those unable to complete the study questionnaires and psychological tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy (SHE) in Management of Sleep Disorders Among Elderly
Sleep disorders are common among elderly persons, with deleterious effects on their physical and mental health. Many approaches are used to manage such disorders. Aim of the study: To compare the Emotional Freedom Techniques-Insomnia (EFT-I) and Sleep Hygiene Education (SHE) group therapy as two treatments for insomnia in a geriatric population when delivered, and their effects on sleep quality, depression, and life satisfaction.
Read the detailed description
Background: Sleep disorders are common among elderly persons, with deleterious effects on their physical and mental health. Many approaches are used to manage such disorders. Aim of the study: To compare the Emotional Freedom Techniques-Insomnia (EFT-I) and Sleep Hygiene Education (SHE) group therapy as two treatments for insomnia in a geriatric population when delivered, and their effects on sleep quality, depression, and life satisfaction. Participants and methods: This open-label randomized controlled trial study was conducted at Elabbasia Mental Hospital and Osana family wellness elderly nursing home at Maadi, Cairo. It included 60 elderly patients suffering insomnia sleep problem randomized into two equal groups: one group received a Sleep Hygiene Education (SHE) intervention, the other had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I). A self-administered questionnaire with tools for sleep quality (Pittsburgh Sleep Quality Index [PSQI]), depression, and life satisfaction was used to collect data. The fieldwork was from January to March 2021.
- Conditions
- Sleep Disorder, Sleep Disorder in Elderly, Sleep Disorder, Mental Health, Sleep Disorders, Physical Health, Sleep Disorder; Insomnia Type, Sleep Hygiene
- Being tested
- The Sleep Hygiene Education (SHE), Emotional Freedom Techniques (EFT)
- Keywords
- Emotional Freedom Techniques, Sleep Hygiene Education Geriatric, Sleep Disorders, Elderly
- Medical subject headings
- Sleep Wake Disorders, Psychological Well-Being, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Sleep Hygiene Education (SHE)Behavioural
Also called Emotional Freedom Techniques (EFT)
Patients were randomized into two equal groups of 30 participants each. One group received a Sleep Hygiene Education (SHE) intervention
Emotional Freedom Techniques (EFT)Behavioural
30 participants had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I).
| Study group | Role | What they receive |
|---|---|---|
| Control (EFT) | Other | had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I) Receives: Behavioral: Emotional Freedom Techniques (EFT) |
| Sleep Hygiene Education (SHE) intervention group | Active comparator | received a Sleep Hygiene Education (SHE) intervention Receives: Behavioral: The Sleep Hygiene Education (SHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
poor quality sleep (PSQI)
The tool consists of 19 items from which seven components covering different aspects of sleep are computed to produce one composite global score. These are sleep latency asking about how long it takes to fall asleep, sleep duration, habitual sleep efficiency measuring the percentage of sleep time of total bedtime, sleep disturbances, use of sleeping medication, daytime dysfunction, in addition to overall subjective sleep quality. Each item is weighted on a 0-3 interval scale, with a higher score indicating worse quality. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. For categorical analysis, the total score in dichotomized into good sleep quality (total score <=5), and poor sleep quality (total score >5) [15].
Measured: The tool filling can be completed in 5-10 minutes
Geriatric Depression Scale (GDS-15)
The Geriatric Depression Scale 15-item version. It also helps in the assessment of the severity of these symptoms and in treatment follow-up. we applied the modifed 15-question shorter version as proposed by Sheikh and Yesavage 1986, and its validity was put in evidence. The tool has 15 items such as: "Are you basically satisfied with your life?", "Do you often get bored?"," Do you feel happy most of the time?", "Do you think that most people are better off than you are?". The response to each item is either Yes or No. These are scored 1 and zero respectively. The scoring was reversed for positive items so that a higher score indicates more severe depression. The scores of the items are summed-up giving a total score ranging from 0 to 15. For categorical analysis, the total score in dichotomized into: no depression (total score <=5), and depression (total score >5). The validated Arabic version of this tool was used in the present study.
Measured: The tool filling can be completed in 5-10 minutes
Satisfaction with Life (SWL) scale
The third tool was the Satisfaction with Life (SWL) scale. This tool was developed by Diener et al. [23], to assess a person's to overall subjective feeling of satisfaction with his/her life. The tool consists of five items such as "In most ways my life is close to my ideal", "If I could live my life over, I would change almost nothing." The responses are on a 7-point Likert type scale ranging from "strongly disagree' to "strongly agree." These are scored from one to seven. The scores of the items are summed-up giving a total score ranging from 5 to 35. For categorical analysis, the total score in dichotomized into: dissatisfied (total score 5-20), and satisfied (total score 21-35). Research demonstrated high tool validity and reliability [24, 25]. Arabic version of this tool was used in the present study.
The validity of this Scale according to Cronbach's alpha was 0.87
Measured: The tool filling can be completed in 5-10 minutes
Pilot study
A pilot study was conducted on six patients representing 10% of computed sample size to test the clarity of the data collection form and the feasibility of the research process. Needed modifications were carried out based on the results of the pilot study, and the tool was finalized accordingly. The patients involved in the pilot were excluded from the study to avoid contamination of the study sample.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start3 Jan 2021
- Primary completion21 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label randomized controlled trial design was utilized in this study. It was open-label because the type of intervention could not be concealed to participants or researchers.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matrouh University
- Sponsor type
- University, hospital or other
- Collaborators
- Beni-Suef University, University of Bisha, Suez Canal University
- Responsible party
- Principal investigator, Nancy Elsakhy, Matrouh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276635
- Sponsor's protocol ID
- 0305317/2021
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy (SHE) in Management of Sleep Disorders Among Elderly
- ClinicalTrials.gov ID
- NCT05276635
- Acronym / sponsor ID
- 0305317/2021
- Conditions
- Sleep Disorder, Sleep Disorder in Elderly, Sleep Disorder, Mental Health, Sleep Disorders, Physical Health, Sleep Disorder; Insomnia Type, Sleep Hygiene
- Keywords
- Emotional Freedom Techniques, Sleep Hygiene Education Geriatric, Sleep Disorders, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Matrouh UniversityUniversity, hospital or other
- Collaborators
- Beni-Suef University, University of Bisha, Suez Canal University
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 11 Mar 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.
Sleep disorders are common among elderly persons, with deleterious effects on their physical and mental health. Many approaches are used to manage such disorders. Aim of the study: To compare the Emotional Freedom Techniques-Insomnia (EFT-I) and Sleep Hygiene Education (SHE) group therapy as two treatments for insomnia in a geriatric population when delivered, and their effects on sleep quality, depression, and life satisfaction.
Detailed description
Background: Sleep disorders are common among elderly persons, with deleterious effects on their physical and mental health. Many approaches are used to manage such disorders. Aim of the study: To compare the Emotional Freedom Techniques-Insomnia (EFT-I) and Sleep Hygiene Education (SHE) group therapy as two treatments for insomnia in a geriatric population when delivered, and their effects on sleep quality, depression, and life satisfaction. Participants and methods: This open-label randomized controlled trial study was conducted at Elabbasia Mental Hospital and Osana family wellness elderly nursing home at Maadi, Cairo. It included 60 elderly patients suffering insomnia sleep problem randomized into two equal groups: one group received a Sleep Hygiene Education (SHE) intervention, the other had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I). A self-administered questionnaire with tools for sleep quality (Pittsburgh Sleep Quality Index [PSQI]), depression, and life satisfaction was used to collect data. The fieldwork was from January to March 2021.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- An open-label randomized controlled trial design was utilized in this study. It was open-label because the type of intervention could not be concealed to participants or researchers.
| Arm | Type | Receives |
|---|---|---|
| Control (EFT) | Other | Behavioral: Emotional Freedom Techniques (EFT)had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I) |
| Sleep Hygiene Education (SHE) intervention group | Active comparator | Behavioral: The Sleep Hygiene Education (SHE)received a Sleep Hygiene Education (SHE) intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients suffering insomnia sleep problem
- Age equal or more than 60 years
Key exclusion criteria (2 listed)
- Those having major physical or psychiatric ailments or being on medication affecting their sleep were excluded
- These involved those history of epilepsy, seizures, or dementia, current alcohol or substance abuse/dependence (must have >90 days of sobriety), night shift workers, as well as those unable to complete the study questionnaires and psychological tests.
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 |
|---|---|---|
| The Sleep Hygiene Education (SHE)Also: Emotional Freedom Techniques (EFT)Patients were randomized into two equal groups of 30 participants each. One group received a Sleep Hygiene Education (SHE) intervention | Behavioural | Sleep Hygiene Education (SHE) intervention group |
| Emotional Freedom Techniques (EFT)30 participants had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I). | Behavioural | Control (EFT) |
Primary outcome
poor quality sleep (PSQI)
Time frame: The tool filling can be completed in 5-10 minutes
The tool consists of 19 items from which seven components covering different aspects of sleep are computed to produce one composite global score. These are sleep latency asking about how long it takes to fall asleep, sleep duration, habitual sleep efficiency measuring the percentage of sleep time of total bedtime, sleep disturbances, use of sleeping medication, daytime dysfunction, in addition to overall subjective sleep quality. Each item is weighted on a 0-3 interval scale, with a higher score indicating worse quality. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. For categorical analysis, the total score in dichotomized into good sleep quality (total score <=5), and poor sleep quality (total score >5) [15].
Geriatric Depression Scale (GDS-15)
Time frame: The tool filling can be completed in 5-10 minutes
The Geriatric Depression Scale 15-item version. It also helps in the assessment of the severity of these symptoms and in treatment follow-up. we applied the modifed 15-question shorter version as proposed by Sheikh and Yesavage 1986, and its validity was put in evidence. The tool has 15 items such as: "Are you basically satisfied with your life?", "Do you often get bored?"," Do you feel happy most of the time?", "Do you think that most people are better off than you are?". The response to each item is either Yes or No. These are scored 1 and zero respectively. The scoring was reversed for positive items so that a higher score indicates more severe depression. The scores of the items are summed-up giving a total score ranging from 0 to 15. For categorical analysis, the total score in dichotomized into: no depression (total score <=5), and depression (total score >5). The validated Arabic version of this tool was used in the present study.
Satisfaction with Life (SWL) scale
Time frame: The tool filling can be completed in 5-10 minutes
The third tool was the Satisfaction with Life (SWL) scale. This tool was developed by Diener et al. [23], to assess a person's to overall subjective feeling of satisfaction with his/her life. The tool consists of five items such as "In most ways my life is close to my ideal", "If I could live my life over, I would change almost nothing." The responses are on a 7-point Likert type scale ranging from "strongly disagree' to "strongly agree." These are scored from one to seven. The scores of the items are summed-up giving a total score ranging from 5 to 35. For categorical analysis, the total score in dichotomized into: dissatisfied (total score 5-20), and satisfied (total score 21-35). Research demonstrated high tool validity and reliability [24, 25]. Arabic version of this tool was used in the present study. The validity of this Scale according to Cronbach's alpha was 0.87
Pilot study
Time frame: two months
A pilot study was conducted on six patients representing 10% of computed sample size to test the clarity of the data collection form and the feasibility of the research process. Needed modifications were carried out based on the results of the pilot study, and the tool was finalized accordingly. The patients involved in the pilot were excluded from the study to avoid contamination of the study sample.
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 11 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Sleep Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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 The Sleep Hygiene Education (SHE) and Emotional Freedom Techniques (EFT) in people with Sleep Disorder and Sleep Disorder in Elderly, run by Matrouh University at 1 site in Egypt.
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 2 inclusion and 2 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 11 Mar 2022. 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 Egypt. 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?
poor quality sleep (PSQI) (time frame: The tool filling can be completed in 5-10 minutes). The study lists 4 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 11 Mar 2022.