"Eye Masks and Post-Surgical Sleep Quality"

NCT05988164 | Enrolling By Invitation

• 1 other identifier: SAU-FHS-KI-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the impact of postoperative eye mask usage on sleep quality in patients who have undergone gynecological surgery.

Conditions

Sleep Quality

Keywords

Eye Mask; Sleep Quality; Gynecological Surgeries; Hospitalization; Health Care

Outcome Measures

Primary Outcomes (1)

• Improving sleep quality with eye mask following gynecological surgery

  Sleep quality and duration are increased in patients undergoing gynecological surgery with the use of postoperative eye masks. This results in reduced sleep interruptions and improved overall healthcare satisfaction and well-being of patients.

  9 months

Study Arms (2)

Eye mask Group

EXPERIMENTAL

Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier. Researchers or nurses will assist patients who cannot wear an eye mask at night. To measure patients' perception of sleep quality, we will use the Richard-Campbell Sleep Scale. The following morning, we will complete the post-test Richard-Campbell Sleep Scale to assess sleep quality.

Other: Eye Mask

control Group

NO INTERVENTION

The control group will undergo no intervention, and their sleep quality will be measured in the hospital setting using the Richard-Campbell Sleep Scale.

Interventions

Eye Mask OTHER

Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier.

Eye mask Group

Eligibility Criteria

• Age: 25 Years - 85 Years
• Gender Eligibility Details: Only females aged 25-85 who underwent gynecological surgery are eligible to participate in this study..
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who have undergone gynecological surgery Ability to read and speak Turkish participation with the ability to use an eye mask Patients who recovered at least six hours after surgery Patients with no traumatic or pathological head injury history Patients without sleep disorders or mental illnesses

You may not qualify if:

• Patients with an eye injury Patients who are allergic to eye masks Patients or their families who wish to withdraw from the study Patients with a mental or physical condition that makes participation in the study impossible.
• Patients who cannot speak or read Turkish

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, 54050, 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: An independent statistician researcher, not directly involved in collecting patient data, will analyze the data to mask the investigator's influence.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosiated Professor

Model Details: There is an intervention group and a control group. Twenty-five participants participated in the intervention and 25 in the control group. Patients in the intervention group will be given eye masks and asked to sleep with them

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: October 5, 2023
• Primary Completion: May 29, 2024
• Study Completion: May 30, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)