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

NCT05276635 | Completed

• 1 other identifier: 0305317/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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) \[15\].

  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.

  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

  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.

  two months

Study Arms (2)

Control (EFT)

OTHER

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

Behavioral: Emotional Freedom Techniques (EFT)

Sleep Hygiene Education (SHE) intervention group

ACTIVE COMPARATOR

received a Sleep Hygiene Education (SHE) intervention

Behavioral: The Sleep Hygiene Education (SHE)

Interventions

The Sleep Hygiene Education (SHE) BEHAVIORAL

Patients were randomized into two equal groups of 30 participants each. One group received a Sleep Hygiene Education (SHE) intervention

Also known as: Emotional Freedom Techniques (EFT)

Sleep Hygiene Education (SHE) intervention group

Emotional Freedom Techniques (EFT) BEHAVIORAL

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

Control (EFT)

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matrouh University: lead
• Beni-Suef University: collaborator
• University of Bisha: collaborator
• Suez Canal University: collaborator

Study Sites (1)

Faculty of Nursing, Matrouh University

Marsá Maţrūḩ, 51511, Egypt

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Psychological Well-Being; Sleep Hygiene

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Personal Satisfaction; Behavior; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This open-label randomised controlled trial study was conducted at Elabbasia Mental Hospital and Osana family wellness elderly nursing home at Maadi, Cairo
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gerontological Nursing

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 11, 2022
• Study Start: January 3, 2021
• Primary Completion: March 21, 2021
• Study Completion: March 31, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)