NCT07137143

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 16, 2025

Last Update Submit

August 26, 2025

Conditions

Keywords

intensive care unithypothermiapostoperative warming

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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).

    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.

    6 months

Study Arms (2)

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

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

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.

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, Yüreğir, 01220, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Cansel Bozer Uludağ, expert

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups, control group and intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
expert

Study Record Dates

First Submitted

August 16, 2025

First Posted

August 22, 2025

Study Start

April 20, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations