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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04244071
Other study ID # Selcuk
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2018
Est. completion date May 30, 2019

Study information

Verified date January 2020
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date May 30, 2019
Est. primary completion date January 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Bair Paws Blanket 81003 and FOC device 87500
This study is a randomized, pretest - posttest controlled experimental design.
Other:
routine hospital care
routine hospital care

Locations

Country Name City State
Turkey Selcuk Universty Konya

Sponsors (2)

Lead Sponsor Collaborator
Selcuk University Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline (at the beginning of treatment)
Primary 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 baseline (at the beginning of treatment)
Secondary 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) baseline (at the beginning of treatment)
Secondary 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) baseline (at the beginning of treatment)
Secondary 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) baseline (at the beginning of treatment)
Secondary respiratory rates the respiratory rate was counted for one minute. (beats per minute) baseline (at the beginning of treatment)
Secondary 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) baseline (at the beginning of treatment)
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