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Sleep Disorder Manage in Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy

Primary Purpose

Sleep Disorder, Sleep Disorder in Elderly, Sleep Disorder, Mental Health

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
The Sleep Hygiene Education (SHE)
Emotional Freedom Techniques (EFT)
Sponsored by
Matrouh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Disorder focused on measuring Emotional Freedom Techniques, Sleep Hygiene Education Geriatric, Sleep Disorders, Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients suffering insomnia sleep problem
  • Age equal or more than 60 years

Exclusion Criteria:

  • 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.

Sites / Locations

  • Faculty of Nursing, Matrouh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control (EFT)

Sleep Hygiene Education (SHE) intervention group

Arm Description

had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I)

received a Sleep Hygiene Education (SHE) intervention

Outcomes

Primary Outcome Measures

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].
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2022
Last Updated
March 1, 2022
Sponsor
Matrouh University
Collaborators
Beni-Suef University, University of Bisha, Saudia Arabia, Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT05276635
Brief Title
Sleep Disorder Manage in Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy
Official Title
Effectiveness of Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy (SHE) in Management of Sleep Disorders Among Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
March 21, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Matrouh University
Collaborators
Beni-Suef University, University of Bisha, Saudia Arabia, Suez Canal 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
This open-label randomised controlled trial study was conducted at Elabbasia Mental Hospital and Osana family wellness elderly nursing home at Maadi, Cairo
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (EFT)
Arm Type
Other
Arm Description
had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I)
Arm Title
Sleep Hygiene Education (SHE) intervention group
Arm Type
Active Comparator
Arm Description
received a Sleep Hygiene Education (SHE) intervention
Intervention Type
Behavioral
Intervention Name(s)
The Sleep Hygiene Education (SHE)
Other Intervention Name(s)
Emotional Freedom Techniques (EFT)
Intervention Description
Patients were randomized into two equal groups of 30 participants each. One group received a Sleep Hygiene Education (SHE) intervention
Intervention Type
Behavioral
Intervention Name(s)
Emotional Freedom Techniques (EFT)
Intervention Description
30 participants had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I).
Primary Outcome Measure Information:
Title
poor quality sleep (PSQI)
Description
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].
Time Frame
The tool filling can be completed in 5-10 minutes
Title
Geriatric Depression Scale (GDS-15)
Description
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.
Time Frame
The tool filling can be completed in 5-10 minutes
Title
Satisfaction with Life (SWL) scale
Description
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
Time Frame
The tool filling can be completed in 5-10 minutes
Title
Pilot study
Description
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.
Time Frame
two months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Male gender, represented by 17(56.7%) and 16 (53.3%) in the EFT and Sleep hygiene groups; respectively. However, Female participants was 13 (43.3%) and 14(46.7%) in both groups respectively.
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients suffering insomnia sleep problem Age equal or more than 60 years Exclusion Criteria: 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.
Facility Information:
Facility Name
Faculty of Nursing, Matrouh University
City
Mersa Matruh
ZIP/Postal Code
51511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Sleep Disorder Manage in Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy

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