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The Effect of Heating on Thermal Comfort and Anxiety

Primary Purpose

Anxiety, Nurse-Patient Relations

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bair Paws Blanket 81003 and FOC device 87500
routine hospital care
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring nursing, active heating, thermal comfort, anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Selcuk Universty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group C

Group A

Group B

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Thermal comfort
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.
Anxiety
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

Secondary Outcome Measures

Body temperatures
In the evaluation of life findings of patients in the perioperative period; ARMOLINE contactless electronic infrared thermometer was used for fire. (degrees centigrade)
blood pressure values
In the evaluation of life findings of patients in the perioperative period; GAMMA brand sphygmomanometer was used for blood pressure. (mm Hg)
pulse values
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)
respiratory rates
the respiratory rate was counted for one minute. (beats per minute)
saturation values
In the evaluation of life findings of patients in the perioperative period; plusMED -50DL finger-type pulse oximeter was used to measure saturation. (PO2)

Full Information

First Posted
January 21, 2020
Last Updated
January 27, 2020
Sponsor
Selcuk University
Collaborators
Koç University
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1. Study Identification

Unique Protocol Identification Number
NCT04244071
Brief Title
The Effect of Heating on Thermal Comfort and Anxiety
Official Title
The Effect of Active and Passive Heating Methods Used in Different Areas of Perioperative Processes on Thermal Comfort and Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
Collaborators
Koç University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study with a randomized, pretest - posttest controlled experimental design was conducted to determine the effects of active and passive heating methods applied in different parts of the perioperative process on thermal comfort, anxiety and vital signs. The study was conducted with the patients who were hospitalized for open abdominal surgical interventions in the Department of Obstetrics and Gynecology, of Selcuk University Medical Faculty Hospital, between the dates of 1 October 2018 and 10 January 2019. The study included 99 patients in two control groups and one experimental group. The patients in group A were dressed with hot air blowing patients scrubs in both preoperative and postoperative periods, while patients in group B were dressed with hot air blowing patients scrubs only in the postoperative period. The control group continued routine practice. In the preoperative period, vital signs, thermal comfort, and anxiety levels of the patients were evaluated. In the intraoperative period, vital signs and thermal comfort levels of the patients were evaluated. Thermal comfort level of the patients was re-evaluated prior to the induction of anesthesia. Once the patients were transferred to the post-anesthesia care unit, among the vital signs of the patients, body temperature was measured in the temporal region, and other signs were measured using the monitors. Thermal comfort and anxiety levels of the patients were re-evaluated after they got dressed.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Nurse-Patient Relations
Keywords
nursing, active heating, thermal comfort, anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bair Paws Blanket 81003 and FOC device 87500
Other Intervention Name(s)
Thermal Comfort Scale, Anxiety Scale
Intervention Description
This study is a randomized, pretest - posttest controlled experimental design.
Intervention Type
Other
Intervention Name(s)
routine hospital care
Intervention Description
routine hospital care
Primary Outcome Measure Information:
Title
Thermal comfort
Description
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.
Time Frame
baseline (at the beginning of treatment)
Title
Anxiety
Description
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
Time Frame
baseline (at the beginning of treatment)
Secondary Outcome Measure Information:
Title
Body temperatures
Description
In the evaluation of life findings of patients in the perioperative period; ARMOLINE contactless electronic infrared thermometer was used for fire. (degrees centigrade)
Time Frame
baseline (at the beginning of treatment)
Title
blood pressure values
Description
In the evaluation of life findings of patients in the perioperative period; GAMMA brand sphygmomanometer was used for blood pressure. (mm Hg)
Time Frame
baseline (at the beginning of treatment)
Title
pulse values
Description
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)
Time Frame
baseline (at the beginning of treatment)
Title
respiratory rates
Description
the respiratory rate was counted for one minute. (beats per minute)
Time Frame
baseline (at the beginning of treatment)
Title
saturation values
Description
In the evaluation of life findings of patients in the perioperative period; plusMED -50DL finger-type pulse oximeter was used to measure saturation. (PO2)
Time Frame
baseline (at the beginning of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinar Tunc Tuna
Organizational Affiliation
Selcuk Universty
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Serife Kursun
Organizational Affiliation
Selcuk Universty
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Inci Kara
Organizational Affiliation
Selcuk Universty
Official's Role
Study Director
Facility Information:
Facility Name
Selcuk Universty
City
Konya
ZIP/Postal Code
42550
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Heating on Thermal Comfort and Anxiety

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