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Completed

NCT Number: NCT06268158

The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit

After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.

It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.Considering possible sample loss, the study was completed with 45 patients, 21 in the experimental group and 24 in the control group.

During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, were used.

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Key information

Conditions

Abdominal Surgery Confusion Delirium Dyssomnias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, Talas, 38080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those who have had abdominal surgery
  • Those who volunteer to participate in the research
  • Those who are over 18 years old
  • Richmond Agitation-Sedation Scale -1, 0, +1
  • Those who have been in intensive care for at least 3 days
  • No communication problems (language, hearing impairment, etc.)
  • No mental problems
  • Patients who do not use sleeping pills or sedating drugs and who do not have alcohol or substance addiction will be included in the study.

Exclusion criteria

  • Those who experience blood loss and fluid electrolyte imbalance after surgery
  • There are contraindications to the use of eye masks (for example, head trauma),
  • Patients with delirium before or after surgery will not be included in the study.

Treatment and study plan

Eye patch

Behavioral

The experimental group will fill out the patient introduction form, Richmond Agitation-Sedation Scale, Nursing Delirium Screening Scale and Richard-Campbell Sleep Scale on the first day. On the 4th day of the study, the Nursing Delirium Screening Scale and the Richard-Campbell Sleep Scale will be completed.

Other names: Music

Primary outcomes

  1. Richard-Campbell Sleep Scale

    Time frame: day 1 and 4 of the study

    It is a scale consisting of 6 items that evaluate the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake when waking up, the quality of sleep and the noise level in the environment. The 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation.

    Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. A score between "0-25" from the scale indicates very poor sleep, and a score between "76-100" indicates very good sleep.

  2. Nursing Delirium Screening Scale

    Time frame: day 1 and 4 of the study

    The scale consists of 5 items, including disorientation, inappropriate behavior, inappropriate communication, illusion-hallucination and slowing down of psychomotor behaviors. Each item in the scale receives a value between 0 and 2 points, and the total score varies between 0 and 10. A score of two and above indicates delirium.

Secondary outcomes

  1. Richmond Agitation-Sedation Scale

    Time frame: day 1

    It is a 10-point scale with four levels indicating anxiety and agitation (1-4), one level indicating calm and alertness (0), and five levels indicating sedation stages (-1;-5). Richmond agitation sedation scale scores range from +4 to -5. Positive RASS scores indicate agitated patients, negative scores indicate sedated or comatose patients.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit Following Abdominal Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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