- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04244071
The Effect of Heating on Thermal Comfort and Anxiety
The Effect of Active and Passive Heating Methods Used in Different Areas of Perioperative Processes on Thermal Comfort and Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
"Perioperative hypothermia," which is defined as a decrease below 36 °C in the body temperature 1 h prior to anesthesia and up to 24 h following anesthesia is a common problem in patients undergoing surgery. Perioperative hypothermia leads to many problems.
Given the negative effects of increased anxiety and deterioration in thermal comfort due to perioperative hypothermia (such as decreased satisfaction and increased pain) hypothermia poses a problem that should be highlighted and prevented. It is also important for nurses to understand hypothermia and the complications associated with it and take effective measures. In the present randomized controlled trials, gowns blowing warm air; heated blankets, fabrics, and liquid; and self-heating blankets were used for increasing thermal comfort. No common heating technique or heating area was used in these studies In this context, the primary purpose of the present study was to determine the effects of active (gown blowing warm air) and passive (heated blanket) heating on thermal comfort and anxiety in preoperative and postoperative periods in patients scheduled for open abdominal surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey, 42550
- Selcuk Universty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being scheduled for open abdominal surgery
- Being an inpatient in the obstetrics and gynecology ward
- 2-4 h surgery duration
- 1 and 2 ASA scores
- Being able to speak Turkish
- Being 18-65 years of age
Exclusion Criteria:
- Mental retardation and psychiatric disorder,
- The presence of severe lesions or wounds on the skin
- Being an alcohol and drug addict
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group C
Usual care (Group C): The patients in this group received routine hospital care. Vital signs, thermal comfort, and anxiety levels of the patients were evaluated. |
routine hospital care
|
Experimental: Group A
The patients in Group A were warmed up using a gown blowing warm air starting at least 30 min prior to the surgery until they were anesthetized. Vital signs, thermal comfort, and anxiety levels of the patients were evaluated. |
This study is a randomized, pretest - posttest controlled experimental design.
Other Names:
|
Experimental: Group B
Routine care was provided for the patients in Group B in the preoperative and intraoperative periods. In the postoperative period, patients were warmed up using a gown blowing warm air after they were transferred to the post-anesthesia care unit, and continued to be warmed up on the basis of the temperature set by themselves until they wore their own clothes in the ward. Vital signs, thermal comfort, and anxiety levels of the patients were evaluated. |
routine hospital care
This study is a randomized, pretest - posttest controlled experimental design.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thermal comfort
Time Frame: baseline (at the beginning of treatment)
|
Thermal comfort level was measured using a 10-cm visual analog scale, The patients were explained that 1 point indicated "no comfort" and 10 points indicated "the highest level of comfort," and then they were asked to give 1-10 points for their comfort levels.
|
baseline (at the beginning of treatment)
|
Anxiety
Time Frame: baseline (at the beginning of treatment)
|
The state-trait anxiety inventory developed by Spielberger et al. (1970) was used to measure the anxiety levels of the patients.
The state anxiety inventory evaluates "how one feels at a certain moment and under certain conditions," whereas the continuous anxiety inventory evaluates "how one feels irrespective of the circumstances and conditions that he or she is in."
A high score is an indicator of high anxiety level
|
baseline (at the beginning of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body temperatures
Time Frame: baseline (at the beginning of treatment)
|
In the evaluation of life findings of patients in the perioperative period; ARMOLINE contactless electronic infrared thermometer was used for fire.
(degrees centigrade)
|
baseline (at the beginning of treatment)
|
blood pressure values
Time Frame: baseline (at the beginning of treatment)
|
In the evaluation of life findings of patients in the perioperative period; GAMMA brand sphygmomanometer was used for blood pressure.
(mm Hg)
|
baseline (at the beginning of treatment)
|
pulse values
Time Frame: baseline (at the beginning of treatment)
|
In the evaluation of life findings of patients in the perioperative period; plusMED -50DL finger-type pulse oximeter was used to measure saturation.
(beats per minute)
|
baseline (at the beginning of treatment)
|
respiratory rates
Time Frame: baseline (at the beginning of treatment)
|
the respiratory rate was counted for one minute.
(beats per minute)
|
baseline (at the beginning of treatment)
|
saturation values
Time Frame: baseline (at the beginning of treatment)
|
In the evaluation of life findings of patients in the perioperative period; plusMED -50DL finger-type pulse oximeter was used to measure saturation.
(PO2)
|
baseline (at the beginning of treatment)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Pinar Tunc Tuna, Selcuk Universty
- Study Director: Serife Kursun, Selcuk Universty
- Study Director: Inci Kara, Selcuk Universty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Selcuk
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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