The Effect of Heating on Thermal Comfort and Anxiety

NCT04244071 | Completed DMC FDA Device

• 1 other identifier: Selcuk
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Nurse-Patient Relations

Keywords

nursing; active heating; thermal comfort; anxiety

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Body temperatures

  baseline (at the beginning of treatment)

• blood pressure values

  baseline (at the beginning of treatment)

• pulse values

  baseline (at the beginning of treatment)

• respiratory rates

  baseline (at the beginning of treatment)

• saturation values

  baseline (at the beginning of treatment)

Study Arms (3)

Group C

ACTIVE COMPARATOR

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.

Other: routine hospital care

Group A

EXPERIMENTAL

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.

Device: Bair Paws Blanket 81003 and FOC device 87500

Group B

EXPERIMENTAL

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.

Device: Bair Paws Blanket 81003 and FOC device 87500; Other: routine hospital care

Interventions

Bair Paws Blanket 81003 and FOC device 87500 DEVICE

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

Also known as: Thermal Comfort Scale, Anxiety Scale

Group A; Group B

routine hospital care OTHER

routine hospital care

Group B; Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being scheduled for open abdominal surgery
• Being an inpatient in the obstetrics and gynecology ward
• h surgery duration
• and 2 ASA scores
• Being able to speak Turkish
• Being 18-65 years of age

You may not qualify if:

• Mental retardation and psychiatric disorder,
• The presence of severe lesions or wounds on the skin
• Being an alcohol and drug addict

Sponsors & Collaborators

• Selcuk University: lead
• Koç University: collaborator

Study Sites (1)

Selcuk Universty

Konya, 42550, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pinar Tunc Tuna

  Selcuk Universty

  STUDY DIRECTOR

• Serife Kursun

  Selcuk Universty

  STUDY DIRECTOR

• Inci Kara

  Selcuk Universty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 28, 2020
• Study Start: March 30, 2018
• Primary Completion: January 10, 2019
• Study Completion: May 30, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)