Impact Of Mindfulness Breathing Versus Storytelling On Non- Specific Insomnia In Elderly

NCT06249607 | Completed DMC

• 1 other identifier: MindfulnessBreathing,Insomnia
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to compare between effects of mindfulness breathing and storytelling on insomnia in the elderly.

Conditions

Insomnia; Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• The Pittsburgh Sleep Quality Index

  Pittsburgh Sleep Quality Index (PSQI) as a valid tool was used to measure the patients' SQ. This instrument was comprised of seven domains, including quality of subjective sleep, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, daytime dysfunction, and use of medication for sleep over the previous month. The score of the domains ranged from 0 = "No difficulty" to 3 = "Severe difficulty". A total score \> 5 was considered to be indicative of poor SQ. A global score between 0 and 21 was derived by summing up the seven subscale scores

  baseline

• Actigraphy

  Actigraph (Actiwatch Minimitter Company, INC - Sunriver, OR, USA) will be placed on the non-dominant wrist and activities will be monitored continuously and recorded at one minute intervals during wakefulness and sleep. The times of wakefulness and sleep will be determined individually through a diary kept by the volunteers, together with the times calculated by the actigraph monitor. The participants will keep the device for a period of 7 days before the first and the last training session. The device will be removed only at bath time and replaced to the wrist immediately after. The information will be collected by the device and recorded by a validated algorithm (Minimitter Company - USA®) and transferred to a closed technology software installed on a computer. After analysis of the exams, the data will be plotted on a spreadsheet for statistical treatment

  baseline

Study Arms (3)

Group A: combined sleep hygiene and storytelling

EXPERIMENTAL

Other: storytelling; Other: Sleep hygiene

Group B: combined sleep hygiene and mindfulness breathing exercise group

EXPERIMENTAL

Other: Mindfulness breathing; Other: Sleep hygiene

Group C: sleep hygiene group

OTHER

Other: Sleep hygiene

Interventions

storytelling OTHER

Storytelling android program: Subjects in group A or the storytelling group will be given headphones to listen to stories for 30 min (i.e., between 9 and 10 pm). While the subject listens to the story, a relative will present in a corner of the room to record when they fell asleep, the relative will present again in the room to record the time of falling asleep. The intervention will be done 7 nights a week for a period of 6 weeks.

Group A: combined sleep hygiene and storytelling

Mindfulness breathing OTHER

android program: Individuals in group B are instructed to "sit upright in a comfortable position with eyes closed," "focus on diaphragm movements while breathing in a slow, deep, relaxed manner," and to nonjudgmentally acknowledge and accept "unwanted thoughts, ideas or images" and "return attention to the diaphragmatic breathing. In this exercise, individuals are instructed to notice the physical sensations of breathing, both inhalations and exhalations, with a focus on the natural rate of respiration as opposed to forcibly controlling the breath. Duration: 5 minutes in duration per session, before sleep for 7 days a week for a total duration of 6 weeks

Group B: combined sleep hygiene and mindfulness breathing exercise group

Sleep hygiene OTHER

Subjects in all groups will receive tips about healthy sleep * Maintain a regular sleep routine. * Avoid daytime naps. * Don't stay in bed awake for more than 5-10 minutes. * Don't watch TV, use the computer, or read in bed. * Drink caffeinated drinks with caution. * Avoid inappropriate substances that interfere with sleep. * Clean fresh air. * Have a quiet, comfortable bedroom.

Group A: combined sleep hygiene and storytelling; Group B: combined sleep hygiene and mindfulness breathing exercise group; Group C: sleep hygiene group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients who have non-specific insomnia for one month at least.
• Their ages \> 65 years.
• Medically stable patients.
• Current complaint of poor SQ (score \> 5 of the SQ scale)
• Body mass index ≤ 35 kg/m2.

You may not qualify if:

• Patients having a well-structured diagnosis of relevant brain illness or
• any disease directly affects sleep.
• Any patient with unstable medical condition
• History of chronic insomnia
• Indication of receiving treatments for depression and anxiety
• Hearing problem

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Naser specialized hospital

Cairo, 3753450, Egypt

Location

Related Links

• ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• mohamed abubakr rabiee, PhD

  physical therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: February 8, 2024
• Study Start: January 5, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 5, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

EG (1)