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

Sleep Clinical Trial

Official title:

The Effect of the Use of Gel Pillows on the Sleep Quality and General Comfort Levels of the Patients in the Preoperative Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06025136
• Other study ID #: 2022-PO198
• Status: Completed
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: September 22, 2023

Study information

• Verified date: November 2023
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Randomization method will be used to determine the groups. Randomization of the patients was done using the 'Random Allocation Software 2.0' program and they are allocated into 2 groups: 1) the control group and 2) the intervenion group.

1. The Control Group: The patients in this group will be visited by the researcher in their rooms on the morning before the surgery. Patients will be informed that they will be visited again in the evening of the day before the surgery and that they will be given a pillow to use while sleeping at night. They 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.

2. The Intervenion Group: The patients in this group will be visited by the researcher in their rooms on the morning before the surgery. Patients will be informed that they will be visited again in the evening of the day before the surgery and that they will be given a pillow to use while sleeping at night. 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. 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 levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 22, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Comfort
• Preoperative
• Sleep

Intervention

Other:
• Using a gel pillow
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.

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comfort level	Comfort level of the patietns will be evalueated with General Comfort Scale. The lowest total score that can be obtained from the scale is 48, and the highest total score is 192. The average value is determined by dividing the total score obtained by the number of scale items, and the result is indicated in the 1-4 distribution. Low comfort is expressed by one point, high comfort by four points.	12 mounth