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NCT Number: NCT07505654

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trakya University

Edirne, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Data Collection Form

    Time frame: Baseline, up to 20 minutes

    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.

  2. Shivering Assessment Scale

    Time frame: Baseline, up to 1 minute

    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.

  3. Thermal Comfort Scale

    Time frame: Baseline, up to1 minute

    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

  4. The thermal comfort inventory

    Time frame: Baseline, up to3 minute

    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.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

The Effect of Using Thermal Blankets on Patients Temperature Comfort and ShiveringLevels Before Open Heart Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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