HypothermiaNCT07505654
The Effect of Using a Thermal Blanket on Temperature and Shivering Levels
A study testing Thermal Blanket and Forced Air Warming Blanket in people with Hypothermia, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The research is planned as a descriptive, cross-sectional, randomized controlled study to evaluate the effect of using thermal blankets on patients' temperature comfort and shivering levels before open heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia
- What is being tested?
- Thermal Blanket and Forced Air Warming Blanket
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2024to 15 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years of age,
- Volunteering to participate in the study,
- Will undergo elective open heart surgery for the first time,
- It will be taken as the first case of the day,
- Absence of monoplegia, hemiplegia, paraplegia, quadriplegia,
- Agreeing to be covered with a thermal blanket or compressed air blanket,
- The absence of limb paralysis was included.
Who cannot join
- Not being over 18 years of age,
- Not volunteering to participate in the study,
- Not having elective open heart surgery for the first time,
- Not to be taken as the first case of the day,
- Having monoplegia, hemiplegia, paraplegia, quadriplegia,
- Not accepting to be covered with a thermal blanket or compressed air blanket,
- Extremity paralysis was included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Thermal Blankets on Patients Temperature Comfort and ShiveringLevels Before Open Heart Surgery
The research is planned as a descriptive, cross-sectional, randomized controlled study to evaluate the effect of using thermal blankets on patients' temperature comfort and shivering levels before open heart surgery.
H1: There is a difference between the effects of using thermal blankets and standard blankets on patients' body temperature in the preoperative period.
Read more
H2: The temperature comfort of patients who use thermal blankets in the preoperative period is higher than patients who do not use them.
H3: The temperature perception of patients who use thermal blankets in the preoperative period is higher than patients who do not use them.
H4: Shivering levels of patients who use thermal blankets in the preoperative period are lower than patients who do not use them.
Participants will be asked to cover themselves with a thermal blanket, forced air warming blanket and standard blanket before surgery.
Researchers will compare study 1, study 2 and control groups to evaluate the effect of using thermal blankets on patients' temperature comfort and shivering levels before open heart surgery.
Read the detailed description
Randomization method will be used to determine the groups. Randomization of the patients was done using the 'Random Allocation Software 1.0' program and the patients were divided into 3 groups: study group 1, study group 2 and control group.
The patients will be visited by the researcher in their rooms on the afternoon before the day of surgery, and then the first part of the data collection form will be filled out in approximately 10 minutes by face-to-face interview. Then, thermal blankets and forced-air warming blankets will be introduced, information will be given about their use according to the stages of the study, and they will be informed that they will meet again the next day in the morning.
Study group patients Patients in this group will be visited in their rooms by the researcher on the morning of surgery. Patients will be given a thermal blanket or forced-air warming blanket to use during the transfer process. Patients will be asked to notify the researcher if they stop using the blanket.A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level.
Controll group patients Patients will be informed that they will be visited on the day of surgery and that they will be given a standard blanket to use during the transfer phases. No other intervention will be made. A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level.
- Conditions
- Hypothermia
- Being tested
- Thermal Blanket, Forced Air Warming Blanket
- Keywords
- Open heart surgery, Preoperative nursing care, Passive heating, Normothermia, Hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal BlanketBehavioural
The thermal blanket to be used in study group 1 patients is designed to maintain the temperature produced by the users' bodies without getting cold or sweating, and has the feature of maintaining the patients' body temperatures. Produced with multi-layer special protection technology, both outer surfaces of the thermal blanket are covered with soft microfiber fabric with water repellent properties.
Forced Air Warming BlanketBehavioural
Forced air warming blanket to be used in study group 2 patients is made of non-woven, soft, light, latex-free material and is designed to transfer heat equally to the entire blanket through controlled diffusion due to its structure that surrounds the patient. It has the feature of maintaining patients' body temperatures throughout the surgery process.
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | Patients in this group will be visited in their rooms by the researcher on the morning of surgery. Patients will be given a thermal blanket to use during the transfer process. Patients will be asked to notify the researcher if they stop using the blanket. A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level. Receives: Behavioral: Thermal Blanket |
| Study Group 2 | Experimental | Patients in this group will be visited in their rooms by the researcher on the morning of surgery. Patients will be given a forced-air warming blanket to use during the transfer process. Patients will be asked to notify the researcher if they stop using the blanket.A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level. Receives: Behavioral: Forced Air Warming Blanket |
| Control Group | No intervention | Patients will be informed that they will be visited on the day of surgery and that they will be given a standard blanket to use during the transfer phases. No other intervention will be made. A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection Form
Data Collection Form" prepared by the research as a result of reviewing the literature was used to collect the data. In the first part of the form, socio-demographic data of the patient (age, gender, marital status, educational status, medical diagnosis, presence of chronic disease, previous surgery experience, cold experience in previous surgery, weight and height, BMI, ASA score), second part. In the section, there was a table where the data regarding the measurement parameters would be recorded. Accordingly, the table included the patient's physiological measurement parameters (pulse, blood pressure, oxygen saturation, body temperature (axillary and tympanic), measurement parameters of the environment related to the preoperative preparation process (ambient temperature and humidity) and the measurement time.
Measured: Baseline, up to 20 minutes
Shivering Assessment Scale
This form, used to define the patient's tremor level, was developed by Badjatia N. et al. 2008 and May T et al. It was created in line with literature knowledge, taking into account the 2011 diagnosis of tremor level through observation. The patient's tremor level is evaluated by observation as 0, no tremor, 1 Mild, localized tremor in the neck/chest area, 2 Intermittent, moderate tremor in the upper extremities, 3 Severe tremor in the trunk, lower and upper extremities.
Measured: Baseline, up to 1 minute
Thermal Comfort Scale
It is an analog scale used to objectively evaluate the patient's temperature and comfort perception. Temperature comfort perception is scored based on the patient's self-report between 0 too cold and 10 too hot. 5 points are considered optimal temperature comfort
Measured: Baseline, up to1 minute
The thermal comfort inventory
It is a 6-point Likert type scale developed by Wagner et al. in 2006 to evaluate the temperature perception of patients in the preoperative period. The Turkish validity and reliability study of the scale was conducted by Leblebicioğlu H. and Khorshtd L. in 2019. The scale evaluates based on patient self-report. It consists of a total of 13 items and 2 factors (Physical and environmental temperature and the person's psychospiritual state). Cronbach's alpha coefficients of the scale were found to be 0.825 for the person's physical and environmental temperature sub-dimension, 0.784 for the person's psychospiritual state sub-dimension, and 0.809 for the general Temperature Comfort Scale. Each item in the scale is scored between 1-6 points (1-Strongly Disagree, 2-Disagree, 3-Partly Disagree, 4-Partly Agree, 5-Agree, 6-Strongly Agree). The negative items on the scale (items 2, 6, 7, 9, 10, 12, and 13). A high score from the scale indicates that the perception of warmth and comfort is high.
Measured: Baseline, up to3 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start29 Apr 2024
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies 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 was designed as a descriptive, cross-sectional, randomized controlled study to evaluate the effect of using thermal blankets on patients' temperature comfort and shivering levels before open heart surgery. Randomization method will be used to determine the groups. For this purpose, patients who meet the study criteria and volunteer will be assigned to groups using the 'Random Allocation Software 1.0' randomization program according to the order of hospitalization.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UTKU DURGUT, Trakya University
- Investigators
- UTKU DURGUT, Study chair, Trakya UniversitySEHER ÜNVER, Study director, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505654
- Sponsor's protocol ID
- TÜTF-GOBAEK 2024/44
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Thermal Blankets on Patients Temperature Comfort and ShiveringLevels Before Open Heart Surgery
- ClinicalTrials.gov ID
- NCT07505654
- Acronym / sponsor ID
- TÜTF-GOBAEK 2024/44
- Conditions
- Hypothermia
- Keywords
- Open heart surgery, Preoperative nursing care, Passive heating, Normothermia, Hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 1 Apr 2026 (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 research is planned as a descriptive, cross-sectional, randomized controlled study to evaluate the effect of using thermal blankets on patients' temperature comfort and shivering levels before open heart surgery.
H1: There is a difference between the effects of using thermal blankets and standard blankets on patients' body temperature in the preoperative period.
H2: The temperature comfort of patients who use thermal blankets in the preoperative period is higher than patients who do not use them.
H3: The temperature perception of patients who use thermal blankets in the preoperative period is higher than patients who do not use them.
H4: Shivering levels of patients who use thermal blankets in the preoperative period are lower than patients who do not use them.
Participants will be asked to cover themselves with a thermal blanket, forced air warming blanket and standard blanket before surgery.
Researchers will compare study 1, study 2 and control groups to evaluate the effect of using thermal blankets on patients' temperature comfort and shivering levels before open heart surgery.
Detailed description
Randomization method will be used to determine the groups. Randomization of the patients was done using the 'Random Allocation Software 1.0' program and the patients were divided into 3 groups: study group 1, study group 2 and control group.
The patients will be visited by the researcher in their rooms on the afternoon before the day of surgery, and then the first part of the data collection form will be filled out in approximately 10 minutes by face-to-face interview. Then, thermal blankets and forced-air warming blankets will be introduced, information will be given about their use according to the stages of the study, and they will be informed that they will meet again the next day in the morning.
Study group patients Patients in this group will be visited in their rooms by the researcher on the morning of surgery. Patients will be given a thermal blanket or forced-air warming blanket to use during the transfer process. Patients will be asked to notify the researcher if they stop using the blanket.A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level.
Controll group patients Patients will be informed that they will be visited on the day of surgery and that they will be given a standard blanket to use during the transfer phases. No other intervention will be made. A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The research was designed as a descriptive, cross-sectional, randomized controlled study to evaluate the effect of using thermal blankets on patients' temperature comfort and shivering levels before open heart surgery. Randomization method will be used to determine the groups. For this purpose, patients who meet the study criteria and volunteer will be assigned to groups using the 'Random Allocation Software 1.0' randomization program according to the order of hospitalization.
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Behavioral: Thermal BlanketPatients in this group will be visited in their rooms by the researcher on the morning of surgery. Patients will be given a thermal blanket to use during the transfer process. Patients will be asked to notify the researcher if they stop using the blanket. A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level. |
| Study Group 2 | Experimental | Behavioral: Forced Air Warming BlanketPatients in this group will be visited in their rooms by the researcher on the morning of surgery. Patients will be given a forced-air warming blanket to use during the transfer process. Patients will be asked to notify the researcher if they stop using the blanket.A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level. |
| Control Group | No intervention | –Patients will be informed that they will be visited on the day of surgery and that they will be given a standard blanket to use during the transfer phases. No other intervention will be made. A data collection form was used to evaluate the patients' physiological parameters, Temperature Comfort Scale, Thermal Comfort Scale were used to evaluate the comfort levels, and the Shivering Assessment Scale was used to evaluate the shivering level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being over 18 years of age,
- Volunteering to participate in the study,
- Will undergo elective open heart surgery for the first time,
- It will be taken as the first case of the day,
- Absence of monoplegia, hemiplegia, paraplegia, quadriplegia,
Key exclusion criteria (7 listed)
- Not being over 18 years of age,
- Not volunteering to participate in the study,
- Not having elective open heart surgery for the first time,
- Not to be taken as the first case of the day,
- Having monoplegia, hemiplegia, paraplegia, quadriplegia,
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 |
|---|---|---|
| Thermal BlanketThe thermal blanket to be used in study group 1 patients is designed to maintain the temperature produced by the users' bodies without getting cold or sweating, and has the feature of maintaining the patients' body temperatures. Produced with multi-layer special protection technology, both outer surfaces of the thermal blanket are covered with soft microfiber fabric with water repellent properties. | Behavioural | Study Group 1 |
| Forced Air Warming BlanketForced air warming blanket to be used in study group 2 patients is made of non-woven, soft, light, latex-free material and is designed to transfer heat equally to the entire blanket through controlled diffusion due to its structure that surrounds the patient. It has the feature of maintaining patients' body temperatures throughout the surgery process. | Behavioural | Study Group 2 |
Primary outcome
Data Collection Form
Time frame: Baseline, up to 20 minutes
Data Collection Form" prepared by the research as a result of reviewing the literature was used to collect the data. In the first part of the form, socio-demographic data of the patient (age, gender, marital status, educational status, medical diagnosis, presence of chronic disease, previous surgery experience, cold experience in previous surgery, weight and height, BMI, ASA score), second part. In the section, there was a table where the data regarding the measurement parameters would be recorded. Accordingly, the table included the patient's physiological measurement parameters (pulse, blood pressure, oxygen saturation, body temperature (axillary and tympanic), measurement parameters of the environment related to the preoperative preparation process (ambient temperature and humidity) and the measurement time.
Shivering Assessment Scale
Time frame: Baseline, up to 1 minute
This form, used to define the patient's tremor level, was developed by Badjatia N. et al. 2008 and May T et al. It was created in line with literature knowledge, taking into account the 2011 diagnosis of tremor level through observation. The patient's tremor level is evaluated by observation as 0, no tremor, 1 Mild, localized tremor in the neck/chest area, 2 Intermittent, moderate tremor in the upper extremities, 3 Severe tremor in the trunk, lower and upper extremities.
Thermal Comfort Scale
Time frame: Baseline, up to1 minute
It is an analog scale used to objectively evaluate the patient's temperature and comfort perception. Temperature comfort perception is scored based on the patient's self-report between 0 too cold and 10 too hot. 5 points are considered optimal temperature comfort
The thermal comfort inventory
Time frame: Baseline, up to3 minute
It is a 6-point Likert type scale developed by Wagner et al. in 2006 to evaluate the temperature perception of patients in the preoperative period. The Turkish validity and reliability study of the scale was conducted by Leblebicioğlu H. and Khorshtd L. in 2019. The scale evaluates based on patient self-report. It consists of a total of 13 items and 2 factors (Physical and environmental temperature and the person's psychospiritual state). Cronbach's alpha coefficients of the scale were found to be 0.825 for the person's physical and environmental temperature sub-dimension, 0.784 for the person's psychospiritual state sub-dimension, and 0.809 for the general Temperature Comfort Scale. Each item in the scale is scored between 1-6 points (1-Strongly Disagree, 2-Disagree, 3-Partly Disagree, 4-Partly Agree, 5-Agree, 6-Strongly Agree). The negative items on the scale (items 2, 6, 7, 9, 10, 12, and 13). A high score from the scale indicates that the perception of warmth and comfort is high.
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 1 Apr 2026.
- Individual participant dataSharing planned: No
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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.
UTKU DURGUT study chair
Trakya University
SEHER ÜNVER study director
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 Thermal Blanket and Forced Air Warming Blanket in people with Hypothermia, 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 7 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 1 Apr 2026. 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?
Data Collection Form (time frame: Baseline, up to 20 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2026.