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NCT Number: NCT04244071

The Effect of Heating on Thermal Comfort and Anxiety

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Nurse-Patient Relations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk Universty

Konya, 42550, Turkey (Türkiye)

About this study

"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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Bair Paws Blanket 81003 and FOC device 87500

Device

This study is a randomized, pretest - posttest controlled experimental design.

Other names: Thermal Comfort Scale, Anxiety Scale

Routine hospital care

Other

routine hospital care

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. respiratory rates

    Time frame: baseline (at the beginning of treatment)

    the respiratory rate was counted for one minute. (beats per minute)

  5. 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)

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Collaborators

  • Koç University

Registry information

Official study title

The Effect of Active and Passive Heating Methods Used in Different Areas of Perioperative Processes on Thermal Comfort and Anxiety

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2020
Registry last updated
Jan 28, 2020

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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