The Effect of Heating on Thermal Comfort and Anxiety

NCT ID: NCT04244071

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2019-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

"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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Nurse-Patient Relations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

routine hospital care

Intervention Type OTHER

routine hospital care

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.

Group Type EXPERIMENTAL

Bair Paws Blanket 81003 and FOC device 87500

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Bair Paws Blanket 81003 and FOC device 87500

Intervention Type DEVICE

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

routine hospital care

Intervention Type OTHER

routine hospital care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bair Paws Blanket 81003 and FOC device 87500

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

Intervention Type DEVICE

routine hospital care

routine hospital care

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Thermal Comfort Scale Anxiety Scale

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Koç University

OTHER

Sponsor Role collaborator

Selcuk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tunc Tuna Pinar, PhD

Research Asistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pinar Tunc Tuna

Role: STUDY_DIRECTOR

Selcuk Universty

Serife Kursun

Role: STUDY_DIRECTOR

Selcuk Universty

Inci Kara

Role: STUDY_DIRECTOR

Selcuk Universty

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Selcuk Universty

Konya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Selcuk

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Waiting Time in the Premedication Room on Anxiety
NCT06477731 ACTIVE_NOT_RECRUITING