Clinical trial NCT06025136: The Effect of the Use of Gel Pillows on the Sleep Quality and General Comfort Levels
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative
Sleep
Comfort
Keywords: comfort
gel pillows
sleep quality
nursing care
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep quality level
timeFrame: 12 mounth
Secondary outcomes:
measure: Comfort level
timeFrame: 12 mounth
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
affiliation: Trakya University
name: Seher Ünver
role: PRINCIPAL_INVESTIGATOR
affiliation: Trakya University
name: Esra Çevik
role: PRINCIPAL_INVESTIGATOR
References: