The Effect of Using a Thermal Blanket on Temperature and Shivering Levels

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.

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia
• Intervention / Treatment: Behavioral: Thermal Blanket; Behavioral: Forced Air Warming Blanket

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Edirne
    • Edirne, Edirne, Turkey (Türkiye), 22030
      • Trakya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group 1; 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.	Behavioral: Thermal Blanket; 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.
Experimental: Study Group 2; 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.	Behavioral: Forced Air Warming Blanket; 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.
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	Baseline, up to3 minute

Collaborators and Investigators

• Sponsor: Trakya University
• Investigators: Study Chair: UTKU DURGUT, Trakya University; Study Director: SEHER ÜNVER, Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Actual): September 15, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hypothermia; Normothermia; Open heart surgery; Passive heating; Preoperative nursing care
• Additional Relevant MeSH Terms: Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypothermia
• Other Study ID Numbers: TÜTF-GOBAEK 2024/44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No