Sleep Clinical Trial - The Effect of the Use of Gel Pillows on the Sleep

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06025136
Study type	Interventional
Source	Trakya University
Contact
Status	Completed
Phase	N/A
Start date	August 8, 2022
Completion date	September 22, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms