Sleep Quality in Surgical Intensive Care

NCT06973252 | Completed DMC

• 1 other identifier: Sleep Quality
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

It is thought that transferring low-cost and easily applicable interventions that can be used to control environmental stressors such as noise and light that negatively affect sleep quality, especially in intensive care environments, into clinical practice will improve the quality of nursing care. It is recommended that complementary interventions that can be used to improve such sleep quality should be tested and supported by new studies. In this study, it was aimed to determine the effect of eye mask on sleep quality in patients admitted to the surgical intensive care unit after abdominal surgery.

Conditions

Nursing Care; Intensive Care Unit ICU; Sleep Quality

Outcome Measures

Primary Outcomes (3)

• Sleep status

  This form was developed by the researcher using the literature on the subject. The form was filled in based on the self-report of the patients. In order to determine the sleep status of the patients, the form included 5 statements: 'I feel tired and sleepy during the day despite sleeping for a sufficient amount of time', 'I have difficulty falling asleep 2-3 nights a week', 'I have to constantly move my legs in bed', 'I have to go to the toilet at least once during the night', 'I wake up tired and with a headache in the morning'.

  On the 3rd postoperative day

• Richmond Agitation Sedation Scale (RASS) Score

  It is a ten-level scale developed by Cook and Palma (1989) in which eye contact, which is not present in other scales, is evaluated following the verbal stimulus. In the scale, a score of '0' indicates the ideal level where the patient is awake and calm, while values up to '+4' reflect increasing agitation and values up to '-5' reflect increasing sedation level. As the scale score increases, it is interpreted as the agitation status of the patients worsens.

  Postoperative 1st, 2nd and 3rd days

• Richard-Campbell Sleep Scale (RCS) Score

  Richard-Campbell Sleep Scale (RCS): In 1987, the Turkish validity and reliability study of the scale was conducted by Richards in 2015 by Özlü and Özer. The scale consists of 6 items evaluating sleep quality, depth of sleep at night, frequency of awakening, ambient sound level, time of staying awake and time to fall asleep. Each item is evaluated on a scale ranging from 0 to 100. A score between '0-25' indicates very poor sleep and a score between '76-100' indicates very good sleep. As the scale score increases, patients' It is interpreted that sleep quality has increased.

  Postoperative 1st, 2nd and 3rd days

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group patients were fitted with an eye mask designed by the researcher by placing a black fabric in the size of the mask between two three-layer surgical masks with Asfor brand soft elastic earphones and stapling the edges. The designed eye mask was cut with scissors according to the shape of the nose so that the mask would fit the eye exactly and prevent the light from entering the eye. A separate mask was used for each patient in the intervention group. Patients who were admitted to the SICU after surgery were evaluated for agitation-pain-delirium at 23:00 on postoperative days 0, 1, and 2, were told to wear their eye masks after the scale application, and the patients were allowed to sleep at 23:00 at the latest. Patients were allowed to remove the eye patch for short periods of time (10 minutes or less at a time) and then put it back on when uncomfortable and when necessary.

Behavioral: Eye masks

Control group

NO INTERVENTION

Control group received the usual care.

Interventions

Eye masks BEHAVIORAL

The intervention group patients were fitted with an eye mask designed by the researcher by placing a black fabric in the size of the mask between two three-layer surgical masks with Asfor brand soft elastic earphones and stapling the edges. The designed eye mask was cut with scissors according to the shape of the nose so that the mask would fit the eye exactly and prevent the light from entering the eye. A separate mask was used for each patient in the intervention group. Patients who were admitted to the NICU after surgery were evaluated for agitation-pain-delirium at 23:00 on postoperative days 0, 1, and 2, were told to wear their eye masks after the scale application, and the patients were allowed to sleep at 23:00 at the latest. Patients were allowed to remove the eye patch for short periods of time (10 minutes or less at a time) and then put it back on when uncomfortable and when necessary.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• had undergone abdominal surgery
• over 18 years of age,
• who speak Turkish,
• who have not received any diagnosis related to mental health,
• who are open to communication and co-operation
• Patients who voluntarily agreed to participate in the study

You may not qualify if:

• patients with a history of neurological or psychiatric disorders
• patients with any eye disease
• patients who are unable or unwilling to wear an eye mask

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Zafer Mahallesi, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Research Assisstant (Principal Investigator)

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 15, 2025
• Study Start: November 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: June 15, 2023
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after publication

Locations

TU (1)