AnxietyNCT04244071
The Effect of Heating on Thermal Comfort and Anxiety
A study testing Bair Paws Blanket 81003 and FOC device 87500 and routine hospital care in people with Anxiety and Nurse-Patient Relations, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Nurse-Patient Relations
- What is being tested?
- Bair Paws Blanket 81003 and FOC device 87500 and routine hospital care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Mental retardation and psychiatric disorder,
- The presence of severe lesions or wounds on the skin
- Being an alcohol and drug addict
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Active and Passive Heating Methods Used in Different Areas of Perioperative Processes 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.
Read the 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.
- Conditions
- Anxiety, Nurse-Patient Relations
- Being tested
- Bair Paws Blanket 81003 and FOC device 87500, routine hospital care
- Keywords
- nursing, active heating, thermal comfort, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bair Paws Blanket 81003 and FOC device 87500Device
Also called Thermal Comfort Scale, Anxiety Scale
This study is a randomized, pretest - posttest controlled experimental design.
routine hospital careOther
routine hospital care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Bair Paws Blanket 81003 and FOC device 87500; Other: routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline (at the beginning of treatment)
Secondary outcomes (5)
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)
Measured: baseline (at the beginning of treatment)
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)
Measured: baseline (at the beginning of treatment)
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)
Measured: baseline (at the beginning of treatment)
respiratory rates
the respiratory rate was counted for one minute. (beats per minute)
Measured: baseline (at the beginning of treatment)
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)
Measured: baseline (at the beginning of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start30 Mar 2018
- Primary completion10 Jan 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Koç University
- Responsible party
- Principal investigator, Tunc Tuna Pinar, PhD, Selcuk University
- Investigators
- Pinar Tunc Tuna, Study director, Selcuk UniverstySerife Kursun, Study director, Selcuk UniverstyInci Kara, Study director, Selcuk Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244071
- Sponsor's protocol ID
- Selcuk
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Active and Passive Heating Methods Used in Different Areas of Perioperative Processes on Thermal Comfort and Anxiety
- ClinicalTrials.gov ID
- NCT04244071
- Acronym / sponsor ID
- Selcuk
- Conditions
- Anxiety, Nurse-Patient Relations
- Keywords
- nursing, active heating, thermal comfort, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- Koç University
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Other: routine hospital careUsual 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 A | Experimental | Device: Bair Paws Blanket 81003 and FOC device 87500The 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 B | Experimental | Device: Bair Paws Blanket 81003 and FOC device 87500, Other: routine hospital careRoutine 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Mental retardation and psychiatric disorder,
- The presence of severe lesions or wounds on the skin
- Being an alcohol and drug addict
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bair Paws Blanket 81003 and FOC device 87500Also: Thermal Comfort Scale, Anxiety ScaleThis study is a randomized, pretest - posttest controlled experimental design. | Device | Group A, Group B |
| routine hospital careroutine hospital care | Other | Group B, Group C |
Primary outcome
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.
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
5 secondary outcomes
Body temperatures
Time frame: baseline (at the beginning of treatment)
blood pressure values
Time frame: baseline (at the beginning of treatment)
pulse values
Time frame: baseline (at the beginning of treatment)
respiratory rates
Time frame: baseline (at the beginning of treatment)
saturation values
Time frame: baseline (at the beginning of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinar Tunc Tuna study director
Selcuk Universty
Serife Kursun study director
Selcuk Universty
Inci Kara study director
Selcuk Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bair Paws Blanket 81003 and FOC device 87500 and routine hospital care in people with Anxiety and Nurse-Patient Relations, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal comfort (time frame: baseline (at the beginning of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.