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

January 31, 2024 updated by: Mohammed Abubaker Rabiee, Cairo University
This study will be conducted to compare between effects of mindfulness breathing and storytelling on insomnia in the elderly.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sufficient sleep is essential for optimum health just a few of the numerous processes occurring during sleep include memory consolidation, clearance of brain metabolites, and restoration of nervous, immune, skeletal, and muscular systems. Despite the significance of adequate sleep, insufficient or disturbed sleep is extremely common. For instance, thirty percent of employed adults report obtaining 6 or fewer hours of sleep per night, approximately one-third of all adults report significant sleep complaints, and the two most common sleep disorders, insomnia and sleep-disordered breathing (SDB), each have prevalence rates exceeding 10% in the adult population. Unfortunately, current approaches to treatment are limited .

Story telling is another common soothing bedtime routine for children that uses pictures and writing. It is also a nursing intervention that can be implemented to comfort hospitalized children with acute illness and increase enthusiasm. Story telling is a recommended activity that enhances sleep duration in children. Furthermore, it is considered a positive bedtime routine, in addition to praying and brushing teeth, compared to maladaptive bedtime routine, such as watching television, playing with gadgets, and playing games with high-level activities .

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 3753450
        • Recruiting
        • Naser specialized hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: combined sleep hygiene and storytelling
Other: storytelling
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.
Other: Sleep hygiene

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.
Experimental: Group B: combined sleep hygiene and mindfulness breathing exercise group
Other: Sleep hygiene

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.
Other: Mindfulness breathing
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
Other: Group C: sleep hygiene group
Other: Sleep hygiene

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pittsburgh Sleep Quality Index
Time Frame: baseline
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
Time Frame: baseline

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: mohamed abubakr rabiee, PhD, Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MindfulnessBreathing,Insomnia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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