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RecruitingNCT07137143Updated Aug 27, 2025

The Effect of Heating the Intensive Care Room in the Early Postoperative Period on Patient Outcomes

An interventional study of 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 Abdominal Surgery Complications and Hypothermia Following Anesthesia, sponsored by Cukurova University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Cukurova University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Apr 2025, registered Aug 2025).
  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Abdominal Surgery Complications
  • Hypothermia Following Anesthesia

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Keywords

  • intensive care unit
  • hypothermia
  • postoperative warming
03

In context

Hypothermia

449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

This study's planned enrollment of 70 is close to the median of 77 across 328 interventional studies indexed under Hypothermia.

Browse Hypothermia studies →

Lead sponsor

Cukurova University is the lead sponsor of 259 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • No intervention
    no intervention group

    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.

  • Experimental
    intervention group

    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

    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.

Interventions

  • OtherThe 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

  4. 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).

    Time frame: 6 months

  5. 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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Oct 2025, 6 months after the start.

Of 132 non-industry interventional studies with no phase under Hypothermia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 6 months is below that.

Counting every sponsor, half of 135 studies reached it within 16 months; a quarter within 6 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2025
First posted
Aug 22, 2025
StartActual
Apr 20, 2025
Primary completionEst.
Oct 30, 2025
CompletionEst.
Oct 30, 2025
Last update
Aug 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07137143
Responsible party
Cansel Bozer (expert, Cukurova University) — Principal investigator
First posted
Aug 22, 2025
Start date
Apr 20, 2025
Primary completion
Oct 30, 2025 (estimated)
Completion
Oct 30, 2025 (estimated)
Last update
Aug 27, 2025

Study contacts

Cansel Bozer Uludağ, expert
Contact
cansel9815@gmail.com
+905434332624

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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