PreoperativeNCT06025136

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

A study testing Using a gel pillow in people with Preoperative and Sleep, run by Trakya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Preoperative, Sleep, Comfort
What is being tested?: Using a gel pillow
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 8 Aug 2022to 22 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Trakya University
Edirne, 22030

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

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.
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.

Conditions: Preoperative, Sleep, Comfort
Being tested: Using a gel pillow
Keywords: comfort, gel pillows, sleep quality, nursing care
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Using a gel pillowOther
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.

Study groups in NCT06025136
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 mounth

Secondary outcomes (1)

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.
Measured: 12 mounth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 202222 Sep 2023

First posted6 Sep 2023
Study start8 Aug 2022
Primary completion8 Aug 2023
Study completion22 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PreoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06025136
Sponsor's protocol ID: 2022-PO198
Status last verified: May 2025
First submitted: 24 Jan 2023
Last updated: 14 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06025136
Acronym / sponsor ID: 2022-PO198
Conditions: Preoperative, Sleep, Comfort
Keywords: comfort, gel pillows, sleep quality, nursing care
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Trakya UniversityUniversity, hospital or other
Study start: 8 Aug 2022 (actual)
Primary completion: 8 Aug 2023 (actual)
Study completion: 22 Sep 2023 (actual)
First posted: 6 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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

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.
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

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Intervention Group	Experimental	Other: Using a gel pillowPatients 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.
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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Using a gel pillowWithin 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.	Other	Intervention Group

Primary outcome

Sleep quality level
Time frame: 12 mounth
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.

1 secondary outcome

Comfort level
Time frame: 12 mounth

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
Individual participant dataSharing planned: No

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RecruitingPhase 2
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Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Recruiting
68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer
Prostate Cancer (Diagnosis), ACP3
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Seher Ünver principal investigator

Trakya University

Esra Çevik principal investigator

Trakya University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Using a gel pillow in people with Preoperative and Sleep, run by Trakya University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep quality level (time frame: 12 mounth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06025136.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.