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

Not Applicable

Completed

• Conditions: Sleep Disorders, Physical Health; Sleep Disorder; Sleep Disorder in Elderly; Sleep Disorder; Insomnia Type; Sleep Disorder, Mental Health; Sleep Hygiene
• Interventions: Behavioral: The Sleep Hygiene Education (SHE); Behavioral: Emotional Freedom Techniques (EFT)

• Registration Number: NCT05276635
• Lead Sponsor: Matrouh University

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.

Study Timeline

• Study Start: 2021-01-03
• Primary Completion: 2021-03-21
• Study Completion: 2021-03-31
• Study First Submitted: 2022-02-19
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-01
• Last Update Submitted: 2022-03-01
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene Education (SHE) intervention group	The Sleep Hygiene Education (SHE)	received a Sleep Hygiene Education (SHE) intervention
Control (EFT)	Emotional Freedom Techniques (EFT)	had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I)

Primary Outcome Measures

Name	Time	Method
Satisfaction with Life (SWL) scale	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
Geriatric Depression Scale (GDS-15)	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.
Pilot study	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.
poor quality sleep (PSQI)	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) \[15\].

Trial Locations

Locations (1)

Faculty of Nursing, Matrouh University; 🇪🇬 Mersa Matruh, Egypt