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

NCT07505654 | Completed

• 1 other identifier: TÜTF-GOBAEK 2024/44
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypothermia

Keywords

Open heart surgery; Preoperative nursing care; Passive heating; Normothermia; Hypothermia

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

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.

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.

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.

Interventions

Thermal Blanket BEHAVIORAL

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.

Study Group 1

Forced Air Warming Blanket BEHAVIORAL

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 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• UTKU DURGUT

  Trakya University

  STUDY CHAIR

• SEHER ÜNVER

  Trakya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analysis will be completed by an independent researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: April 1, 2026
• Study Start: April 29, 2024
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)