Abdominal Surgery ComplicationsNCT07137143
The Effect of Heating the Intensive Care Room in the Early Postoperative Period on Patient Outcomes
A study testing The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased. in people with Abdominal Surgery Complications and Hypothermia Following Anesthesia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of heating the intensive care room in the early postoperative period on patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery Complications, Hypothermia Following Anesthesia
- What is being tested?
- The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The following criteria will be included in the sample:
- Patients who underwent elective abdominal surgery and were admitted to intensive care after surgery.
- Patients aged 18 and over.
- Patients whose body temperature on the morning of surgery was neither below 36°C nor above 37.5°C.
- Patients who did not have a pacemaker, dementia, advanced spasticity, muscle atrophy, peripheral lesions, osteoporosis, skin irritation, diabetes, hypertension, or obesity.
- Patients who did not require mechanical ventilation.
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- Patients who did not have any illness that would impair thermoregulation (such as head trauma or hypothalamic damage).
- Patients who were not taking medications that would affect thermoregulation, such as vasodilators.
- Patients who did not have peripheral circulation problems.
- Patients who were not alcohol or substance abusers.
- Patients who did not have mental retardation.
- Patients who were conscious and oriented to person, time, and place.
- Patients who could speak Turkish.
- Patients who did not have any auditory or visual impairments.
- Patients who volunteered for the study.
Who cannot join
- Patients who do not meet the sampling criteria, who develop postoperative complications (bleeding, intubation, stenosis, necrosis, ileus, dermatitis, parastomal herniation, etc.), and whose relatives do not consent to the study will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adana City Training and Research Hospital
Adana, Yüreğir, 01220
Cansel Bozer Uludağ, Expert, +905434332624, cansel9815@gmail.com
About this study
The aim of this study was to evaluate the effect of heating the intensive care room in the early postoperative period on patient outcomes.
Read the detailed description
Hypothermia is defined as a drop in body temperature below 35°C, and patients are at high risk during the perioperative period.Unintentional hypothermia can begin before anesthesia and continue for up to the first 24 hours postoperatively.Its incidence varies between 50% and 90% depending on the patient's medical condition, the nature of the surgery, and operating room conditions.Hypothermia leads to complications such as arrhythmia, hypertension, angina, coagulopathy, increased oxygen demand, nausea, vomiting, and delayed wound healing.Additionally, adverse effects such as shivering, changes in cognitive function, decreased patient comfort, and prolonged hospital stay are also observed.The development of hypothermia is influenced by anesthesia-related thermoregulation impairment, a cold operating room environment, and prolonged operations.Patients report experiencing intense chills and shivering, especially in the postoperative period.
This increases anxiety and negatively impacts patient satisfaction and comfort. Guidelines recommend the use of passive and active warming methods to prevent unintended hypothermia.However, no studies have been found in the literature examining the effect of heating the patient room in the postoperative period.In this regard, our study was designed to evaluate the effect of heating the intensive care room in the early postoperative period on patient outcomes and to contribute to the literature.
- Being tested
- The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased.
- Keywords
- intensive care unit, hypothermia, postoperative warming
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased.Other
The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased.
| Study group | Role | What they receive |
|---|---|---|
| no intervention group | No intervention | In the preoperative period, patients with a body temperature of 36°C-37°C one hour before surgery will be included in the sample. Postoperatively, upon arrival from the operating room to the intensive care unit, which has a humidity range of 55%-65% and a temperature range of 22°C-25°C, will be safely transferred to a single-bed room, monitored, and wiped down. After ensuring personal hygiene, the patient will be covered with a 160x220cm cotton quilt. The heating device hose will be placed inside the bed from the side of the bed. The electric heater will be operated at 38°C (Medium) for 120 minutes, 15 cm from the patient's body. Routine treatment and care will then be administered. Vital signs, shivering level, and temperature perception will be recorded on the patient's follow-up form at 0, 15, 30, 45, 60, 90, and 120 minutes postoperatively. |
| intervention group | Experimental | In the preoperative period, patients with a body temperature of 36°C to 37°C one hour before surgery will be included in the sample. In the postoperative period, the intensive care room, which has a routine humidity range of 55%-65% and a temperature of 22°C to 25°C, will be heated to the upper limit of the intensive care room temperature range, 27°C, with an electric heater half an hour before the operation. After ensuring personal hygiene, the patient will be safely transferred to the bed in the single room, monitored, and wiped down. After ensuring personal hygiene, the patient will be covered with a 160x220cm cotton quilt. The heating device hose will be placed inside the bed from the edge of the bed. The electric heater will be operated at 38°C (Medium Level) for 120 minutes, 15cm from the patient's body. Routine treatment and maintenance will be administered. Then, the vital signs, pain, shivering level, and temperature perception will be recorded in the patient follow-up form a Receives: Other: The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Thermal Comfort Scale (TKS)
The Thermal Comfort Scale (TKS) is a Likert-type scale developed by Wagner and colleagues in 2006. Although it was developed to assess the thermal comfort perception of preoperative patients, the authors state that it is also suitable for evaluating conscious postoperative patients. The scale assesses the patient's thermal comfort perception based on self-report. The scale consists of 13 items, each scored from 1 to 6. A higher score indicates a higher thermal comfort perception.
Measured: 6 months
Temperature Comfort Perception Scale (TPS)
The Temperature Comfort Perception Scale is a visual analog scale developed by Wagner and colleagues to objectively assess patients' perception of temperature comfort. It is scored based on patient self-reporting from 0 (extremely cold) to 10 (extremely hot), with a score of 5 representing optimal temperature comfort.
Measured: 6 months
Numerical Pain Assessment Scale (SAS)
This study planned to use a 10-point pain scale, with 0 representing no pain and 10 representing the most unbearable pain. In the study, patients will be asked to select the number that best describes their pain intensity.
Measured: 6 months
Tremor Level Assessment Scale (TRS)
Tremor Level Assessment Scale (TRS) This form, used to assess patients' tremor levels, was developed based on literature. The form was developed using the studies of Badjaita et al. (2008) and May et al. (2011), and was based on criteria for determining the level of tremor based on observation. Tremor level will be assessed based on observation as follows: 0 (absent), 1 (mild; tremor localized only to the neck and/or thorax), 2 (moderate; tremor in the neck, thorax, and upper extremities), and 3 (severe; tremor in the trunk, upper, and lower extremities).
Measured: 6 months
Patient Monitoring Form (PMP)
Patient Monitoring Form (PMP) This form was developed by researchers based on a literature review to monitor the body temperature, blood pressure, pulse, respiration, pain, oxygen saturation, shivering levels, thermal comfort perception, and thermal comfort levels of patients in the intervention and control groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start20 Apr 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Surgery ComplicationsStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups, control group and intervention group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansel Bozer, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137143
- Sponsor's protocol ID
- CU-SBF-CB-05
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 27 Aug 2025
- 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heating the Intensive Care Room in the Early Postoperative Period on Patient Outcomes
- ClinicalTrials.gov ID
- NCT07137143
- Acronym / sponsor ID
- CU-SBF-CB-05
- Keywords
- intensive care unit, hypothermia, postoperative warming
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 22 Aug 2025 (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 aim of this study was to evaluate the effect of heating the intensive care room in the early postoperative period on patient outcomes.
Detailed description
Hypothermia is defined as a drop in body temperature below 35°C, and patients are at high risk during the perioperative period.Unintentional hypothermia can begin before anesthesia and continue for up to the first 24 hours postoperatively.Its incidence varies between 50% and 90% depending on the patient's medical condition, the nature of the surgery, and operating room conditions.Hypothermia leads to complications such as arrhythmia, hypertension, angina, coagulopathy, increased oxygen demand, nausea, vomiting, and delayed wound healing.Additionally, adverse effects such as shivering, changes in cognitive function, decreased patient comfort, and prolonged hospital stay are also observed.The development of hypothermia is influenced by anesthesia-related thermoregulation impairment, a cold operating room environment, and prolonged operations.Patients report experiencing intense chills and shivering, especially in the postoperative period.
This increases anxiety and negatively impacts patient satisfaction and comfort. Guidelines recommend the use of passive and active warming methods to prevent unintended hypothermia.However, no studies have been found in the literature examining the effect of heating the patient room in the postoperative period.In this regard, our study was designed to evaluate the effect of heating the intensive care room in the early postoperative period on patient outcomes and to contribute to the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups, control group and intervention group
| Arm | Type | Receives |
|---|---|---|
| no intervention group | No intervention | –In the preoperative period, patients with a body temperature of 36°C-37°C one hour before surgery will be included in the sample. Postoperatively, upon arrival from the operating room to the intensive care unit, which has a humidity range of 55%-65% and a temperature range of 22°C-25°C, will be safely transferred to a single-bed room, monitored, and wiped down. After ensuring personal hygiene, the patient will be covered with a 160x220cm cotton quilt. The heating device hose will be placed inside the bed from the side of the bed. The electric heater will be operated at 38°C (Medium) for 120 minutes, 15 cm from the patient's body. Routine treatment and care will then be administered. Vital signs, shivering level, and temperature perception will be recorded on the patient's follow-up form at 0, 15, 30, 45, 60, 90, and 120 minutes postoperatively. |
| intervention group | Experimental | Other: The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased.In the preoperative period, patients with a body temperature of 36°C to 37°C one hour before surgery will be included in the sample. In the postoperative period, the intensive care room, which has a routine humidity range of 55%-65% and a temperature of 22°C to 25°C, will be heated to the upper limit of the intensive care room temperature range, 27°C, with an electric heater half an hour before the operation. After ensuring personal hygiene, the patient will be safely transferred to the bed in the single room, monitored, and wiped down. After ensuring personal hygiene, the patient will be covered with a 160x220cm cotton quilt. The heating device hose will be placed inside the bed from the edge of the bed. The electric heater will be operated at 38°C (Medium Level) for 120 minutes, 15cm from the patient's body. Routine treatment and maintenance will be administered. Then, the vital signs, pain, shivering level, and temperature perception will be recorded in the patient follow-up form a |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The following criteria will be included in the sample:
- Patients who underwent elective abdominal surgery and were admitted to intensive care after surgery.
- Patients aged 18 and over.
- Patients whose body temperature on the morning of surgery was neither below 36°C nor above 37.5°C.
- Patients who did not have a pacemaker, dementia, advanced spasticity, muscle atrophy, peripheral lesions, osteoporosis, skin irritation, diabetes, hypertension, or obesity.
Key exclusion criteria (1 listed)
- Patients who do not meet the sampling criteria, who develop postoperative complications (bleeding, intubation, stenosis, necrosis, ileus, dermatitis, parastomal herniation, etc.), and whose relatives do not consent to the study will not be included in the study.
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 |
|---|---|---|
| The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased.The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased. | Other | intervention group |
Primary outcome
The Thermal Comfort Scale (TKS)
Time frame: 6 months
The Thermal Comfort Scale (TKS) is a Likert-type scale developed by Wagner and colleagues in 2006. Although it was developed to assess the thermal comfort perception of preoperative patients, the authors state that it is also suitable for evaluating conscious postoperative patients. The scale assesses the patient's thermal comfort perception based on self-report. The scale consists of 13 items, each scored from 1 to 6. A higher score indicates a higher thermal comfort perception.
Temperature Comfort Perception Scale (TPS)
Time frame: 6 months
The Temperature Comfort Perception Scale is a visual analog scale developed by Wagner and colleagues to objectively assess patients' perception of temperature comfort. It is scored based on patient self-reporting from 0 (extremely cold) to 10 (extremely hot), with a score of 5 representing optimal temperature comfort.
Numerical Pain Assessment Scale (SAS)
Time frame: 6 months
This study planned to use a 10-point pain scale, with 0 representing no pain and 10 representing the most unbearable pain. In the study, patients will be asked to select the number that best describes their pain intensity.
Tremor Level Assessment Scale (TRS)
Time frame: 6 months
Tremor Level Assessment Scale (TRS) This form, used to assess patients' tremor levels, was developed based on literature. The form was developed using the studies of Badjaita et al. (2008) and May et al. (2011), and was based on criteria for determining the level of tremor based on observation. Tremor level will be assessed based on observation as follows: 0 (absent), 1 (mild; tremor localized only to the neck and/or thorax), 2 (moderate; tremor in the neck, thorax, and upper extremities), and 3 (severe; tremor in the trunk, upper, and lower extremities).
Patient Monitoring Form (PMP)
Time frame: 6 months
Patient Monitoring Form (PMP) This form was developed by researchers based on a literature review to monitor the body temperature, blood pressure, pulse, respiration, pain, oxygen saturation, shivering levels, thermal comfort perception, and thermal comfort levels of patients in the intervention and control groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The rooms of the intervention group patients will be heated before they come to intensive care and the temperature of the room will be increased. in people with Abdominal Surgery Complications and Hypothermia Following Anesthesia, run by Cukurova 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 15 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cansel Bozer Uludağ, expert (+905434332624, cansel9815@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Thermal Comfort Scale (TKS) (time frame: 6 months). The study lists 5 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 27 Aug 2025.