The Effect of Ergonomic Sleep Mask Usage on Patients' Sleep Quality and Comfort

NCT05297188 | Completed

• 1 other identifier: 2020-FEN-B-010
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

In intensive care units, the sleep quality of patients decreases considerably due to reasons such as alarm sounds of some special devices, the number of healthcare professionals working in comparison to other clinics, their circulation is high, and the lights are constantly on.Studies conducted in intensive care units to facilitate the transition of patients to sleep and to improve sleep quality;has revealed that non-pharmacological applications increase sleep time and quality, reduce sleep disturbance,delirium,post-traumatic stress disorder and duration of stay in the intensive care unit.Although wearing earplugs and eye masks is a cost-effective and safe method and can improve perceived sleep quality in patients,eye masks and ear plugs are sometimes not comfortable.While the ear plugs dislocate during night sleep may cause the patients to wake up again,there are also situations such as the eye masks not being sized properly for the patients' eyes,and the part of the mask surrounding the head is thin and tense, disturbing the patient.By eliminating this situation that disturbs the patients, other solutions are needed to increase the quality of sleep without being affected by intensive care light and noise. The project was planned to determine the effect of the ergonomic sleep mask on the sleep quality and comfort of patients in surgical patients whose treatment and care continues in intensive care units.The sample of the project consists of 128 patients by performing power analysis.Patients will be divided into two groups as 64 randomized patients in the control and experimental groups by applying block randomization.While there is no application to the experimental and control groups on the first night, an ergonomic sleep mask will be worn to the experimental group,and an ear plug and eye mask will be worn to the control group.At the end of the first night and the second night, the sleep quality of the patients will be evaluated with the 'Richard Campell Sleep Scale' and their comfort levels with the 'Visual Analogue Scale'.The data of the project will be collected using the Patient Information Form prepared in accordance with the literature. In the analysis of the data,Mann-Whitney U test, t test in independent groups, one-way ANOVA test and correlation analysis will be done.

Conditions

Sleep; Patient Compliance; Intensive Care Unit Acquired Weakness

Keywords

intensive care nursıng; surgıcal patient; sleep; ergonomic sleep mask

Outcome Measures

Primary Outcomes (2)

• To compare the effects of using ergonomic sleep mask and ear plugs and eye mask on the comfort levels of patients in intensive care unit.

  The effects on the comfort levels of the patients will be measured with the Visual Analog Scale. Visual Analog Scale: Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients (knee replacement, hyster-ectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) (11). Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale not a visual one.

  1 year

• To compare the effects of using ergonomic sleep mask and ear plugs and eye mask on sleep quality of patients in intensive care unit.

  The effects on the sleep quality of the patients will be measured with the Richard-Campbell Sleep Scale. Richard-Campbell Sleep Scale: Developed by Richards in 1987, the RCSQ is a 6-item scale that evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. A score of "0-25" from the scale indicates very bad sleep, and a score of "76-100" indicates very good sleep. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. As the score of the scale increases, the sleep quality of the patients also increases. The Cronbach α value of the scale developed by Richards was found to be 0.82.

  1 year

Secondary Outcomes (7)

• To examine the effects of the type of anesthesia applied during the surgery on comfort of the patients staying in the intensive care units after surgery.

  1 year

• To examine the effects of the type of anesthesia applied during the surgery on sleep quality of the patients staying in the intensive care units after surgery.

  1 year

• To examine the effects of the type of surgery applied to patients on the sleep quality of patients staying in the intensive care units after surgery.

  1 year

• To examine the relationship between the socio-demographic characteristics of patients and their comfort status in the intensive care units.

  1 year

• To examine the relationship between the socio-demographic characteristics of patients and their sleep quality in the intensive care units.

  1 year

Study Arms (2)

experimental group

Patients will be divided into experimental and control groups by block randomization. No application will be applied to the experimental group for first night sleep. On the morning of the first night, patients' comfort levels and sleep quality will be measured by Visual Analogue Scale and Richard-Campbell Sleep Scale. The second night, an ergonomic sleep mask will be worn to this group. In the morning of the second night, patients' comfort and sleep quality will be measured with the same scales. The patients will be asked to sleep between 22.00 and 24.00 on the second night, and intensive care lights will decrease, the noise level will be minimized, and patients will not wake up during the night outside their treatment.

Device: ergonomic sleep mask

control group

Patients will be divided into experiment and control groups by block randomization. No application will be made to the control group for sleep on the first night. On the morning of the first night, patients' comfort levels and sleep quality will be measured by Visual Analogue Scale and Richard-Campbell Sleep Scale. On the second night, ear plugs and eye mask will be worn to this group. In the morning of the second night, patients' comfort and sleep quality will be measured with the same scales. Patients will be asked to sleep between 22.00 and 24.00 on the second night, and intensive care lights will decrease, noise level will be minimized and patients will not wake up during the night outside their treatment. It will be collected using the form.

Interventions

ergonomic sleep mask DEVICE

Ergonomic sleep mask; It is a material that covers the eye and ear completely and can be adjusted according to the patient, can be washed and reused at 30 degrees after use, 95% cotton, 5% polyester structure and 100% light proof properties.

experimental group

Eligibility Criteria

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

Study Population

The population of the study, treatment and care in the intensive care unit of a public hospital attached to the Ministry of Health in Turkey consist of all patients who sustain. The sample group; after surgery, admitted to the intensive care unit and hospitalized within the first 24 hours, volunteering to participate in the study, communicable with patients 18 years of age and older (with a minimum of 12 GCS score), stable vital signs (arterial blood pressure, heartbeat rate, oxygen saturation, body temperature) will be created from patients. According to the literature review, the sample size was calculated as 128 using the G-POWER program with 0.5 effect size, 80% power and 0.5 error margin. Randomization will be made in the experimental and control groups, 64 patients each.

You may qualify if:

• Acceptance for treat and care of intensive care unit following surgery
• Inpatient stay in the first 24 hours
• Volunteering to participate in the research
• Being 18 years of age or older
• Being able to communicate (patients with a minimum of Glaskow Coma Scale score of 12)
• Stable vital signs (arterial blood pressure, heart rate, oxygen saturation, body temperature)

You may not qualify if:

• No surgical intervention
• The length of stay in the intensive care unit after the surgery is not on the first day
• Having head, neck, ear and eye surgery
• Having eye and ear infections
• Chronic sleep disorder experience
• Sedation
• Having an allergy
• Depending on invasive or noninvasive mechanical ventilation
• Using assistive hearing aids
• Finding vision loss
• No communication

Sponsors & Collaborators

• Bartın Unıversity: lead
• Zonguldak Ataturk State Hospital: collaborator

Study Sites (1)

Bartın University

Merkez, Bartın, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 28, 2022
• Study Start: September 1, 2020
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)