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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07505654
Enrollment
105
Registered
2026-04-01
Start date
2024-04-29
Completion date
2025-09-15
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia

Keywords

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

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.

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.

Interventions

BEHAVIORALThermal 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.

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.

Sponsors

Trakya University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Data analysis will be completed by an independent researcher.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Data Collection FormBaseline, up to 20 minutesData 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.
Shivering Assessment ScaleBaseline, up to 1 minuteThis 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.
Thermal Comfort ScaleBaseline, up to1 minuteIt 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
The thermal comfort inventoryBaseline, up to3 minuteIt 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.

Countries

Turkey (Türkiye)

Contacts

STUDY_CHAIRUTKU DURGUT

Trakya University

STUDY_DIRECTORSEHER ÜNVER

Trakya University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026