NCT05564351

Brief Summary

This study was conducted as a pre-test and post-test randomized controlled single center study to evaluate the effect of ear plugs and eye mask application on sleep quality in patients hospitalized in the intensive care unit. 120 patients who received inpatient treatment in Siirt State Hospital general intensive care unit constitute the sample of the study. The sample consist of four groups: ear plug group (n=30), eye mask group (n=30), earplug-eye mask group (n=30) and control group (n=30). Data were collected using the "Patient Identification Form, Glasgow Coma Skale, Visual Analog Scale, Richards-Campbell Sleep Questionnaire (RCSQ), ear plug and eye mask". As a preliminary test, RCSQ was applied in the morning of the second day after the first night sleep of the patients. Then, according to the group they were assigned to, the patients were allowed to sleep by applying only ear plug, eye mask only and simultaneous ear plug-eye mask between 22:00-06:00. As a final test, RCSQ was readministered to patients on the morning of the third day after the second night's sleep. During the analysis of the data, frequency, number, mean, Student t test and/or Mann- Whitney U test, ANOVA and/or Kruskal- Wallis test, t test or Wilcoxon Sign test, chi-square test were used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 28, 2022

Last Update Submit

September 28, 2022

Conditions

Sleep Quality

Keywords

Nursing, intensive care unit, ear plug, eye mask, sleep quality

Outcome Measures

Primary Outcomes (1)

  • Richards Campbell Sleep Scale

    RCSS is a six-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of waking, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment.

    Three day

Secondary Outcomes (1)

  • Visual Analog Scale

    Three day

Other Outcomes (2)

  • Glasgow Coma Scale

    Three day

  • Patient Information Form

    one day

Study Arms (4)

Ear plug group

EXPERIMENTAL
Other: eye mask and ear plug

Eye mask group

EXPERIMENTAL
Other: eye mask and ear plug

Eye mask+Ear plug group

EXPERIMENTAL
Other: eye mask and ear plug

Control group

NO INTERVENTION

Interventions

eye mask and ear plugOTHER

black eye mask and silicon ear plug

Ear plug groupEye mask groupEye mask+Ear plug group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years or older
  • Being literate
  • No hearing impairment
  • Ability to communicate verbally
  • Receiving inpatient treatment in the GICU for at least 3 days
  • Have 15 Glasgow Coma Scale (GCS) scores (Minimum scores will be as follows. 3 points from eye response; 5 points from motor response; 2 points from verbal response)
  • Agreeing to participate in the research

You may not qualify if:

  • Having a Visual Analog Scale (VAS) score above 7
  • Using sleeping pills or sedative drugs
  • Being treated with a diagnosis of sleep disorder
  • Being on mechanical ventilation
  • Having an active ear or eye infection
  • Having a diagnosed psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siirt State Hospital

Siirt, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective EquipmentProtective DevicesEquipment and SuppliesProtective ClothingClothingManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

October 10, 2021

Primary Completion

May 30, 2022

Study Completion

June 1, 2022

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)