The Effect of the Use of Gel Pillows on the Sleep Quality and General Comfort Levels

NCT06025136 | Completed DMC

• 1 other identifier: 2022-PO198
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study was conducted to evaluate the effect of using gel pillows on the sleep quality and general comfort levels of patients in the preoperative period.The main hypotheses are: H1: 'The sleep quality of patients who use gel pillows in the preoperative period is higher than those who do not use gel pillows' H2: "The general comfort level of the patients who used gel pillows in the preoperative period is higher than those who did not use gel pillows". Participants will be asked to use a gel pillow with a cooling surface the night before the day of surgery. If there is a comparison group: Researchers will compare patients' control group to see if there is any difference in sleep quality and comfort levels.

Conditions

Preoperative; Sleep; Comfort

Keywords

comfort; gel pillows; sleep quality; nursing care

Outcome Measures

Primary Outcomes (1)

• Sleep quality level

  Sleep quality of the patietns will be evaluated with Richards Campbell Sleep Scale. Each item in the scale is evaluated on a chart between 0 and 100 using the visual analog scale technique. 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. A score of "0-25" from the scale indicates very bad sleep, and a score of "76-100" indicates very good sleep. The high score of the scale indicates that the sleep quality of the patients is high.

  12 mounth

Secondary Outcomes (1)

• Comfort level

  12 mounth

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients who are visited in their rooms on the evening of the day before the surgery will be given a gel pillow with a cooling surface feature for night use. Patients will be asked to note the time they go to bed for a night's sleep and the time they wake up on the morning of the surgery. If patients stop using pillows at night, they will be asked to inform the investigator when they come to their room in the morning.Patients will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale to evaluate comfort.

Other: Using a gel pillow

Control Group

NO INTERVENTION

The patients who were visited in their rooms on the evening of the day before the operation will be given pillows that have the same characteristics as the pillows that the patients in the study group will use, but do not have a gel surface, to use at night. Patients will be asked to note the time they go to bed for a night's sleep and the time they wake up on the morning of the surgery.Participants in the control group will receive no other interventions.Patients will be visited again on the morning of the surgery day.The Richard Campbell Sleep Scale was used to evaluate the nighttime sleep quality of the patients;General Comfort Scale to evaluate comfort levels.

Interventions

Using a gel pillow OTHER

Within the scope of the study, gel pillows with a cold surface were used in the patients in the study group. It is produced by combining the obtained special liquid with elastic material with NASA approved molecule exchange technology and is made of OEKO-TEX CLASS 1 certified material.Thanks to the gel material on the pillow surface, the surface temperature is reduced from 37°C to 24°C in about 10 seconds. It gives a feeling of coolness with its thermal conductivity feature.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To research;
• Planned elective surgery
• Those who will undergo cancer surgery related to the gastrointestinal system
• No diagnosis of sleep disorder
• No sensory, cognitive or mental disability
• Using pillows while sleeping
• Patients who volunteered to participate in the study were included.

You may not qualify if:

• Emergency surgical intervention will be performed
• In contact isolation
• The one who has given up using a gel pillow for sleep at night
• Diagnosis of diseases related to the endocrine system (such as diabetes, obesity)
• Using hormone replacement medication
• Patients using anti-depressant medication were excluded.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, 22030, 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 Officials

• Seher Ünver

  Trakya University

  PRINCIPAL INVESTIGATOR

• Esra Çevik

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data analyse is going to be completed by a independent researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The research will be conducted using randomized controlled, experimental type and single-blind research methods. For this purpose, after the data are collected, they will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. Randomization method will be used to determine the groups. For this, the patients who meet the study criteria and volunteer will be assigned to the groups using the randomization program 'Random Allocation Software 2.0' according to the order of hospitalization.

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: September 6, 2023
• Study Start: August 8, 2022
• Primary Completion: August 8, 2023
• Study Completion: September 22, 2023
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)