Scales, Repression-SensitizationNCT04009018
Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties
A study testing Perioperative Satisfaction Scale in Regional Anesthesia in people with Scales, Repression-Sensitization and Anesthesia Awareness, run by Ömer Faruk Boran at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to determine the psychometric properties of Perioperative Satisfaction Scale in Regional Anesthesia. In the Turkish version of the scale, a blind reverse translation method will use. And validity and reliability analyses will conduct. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scales, Repression-Sensitization, Anesthesia Awareness
- What is being tested?
- Perioperative Satisfaction Scale in Regional Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2019to 1 Mar 2020
- 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
- Volunteer to participate in the research
- Participants are over 18 years of age
- Provided regional anesthesia
- Postoperative second day
- No cognitive problems in self-expression
Who cannot join
- Lack of Turkish literacy
- Use of anesthesia technique other than regional anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaras Sutcu Imam University
Kahramanmaraş, 46100
Omer Faruk Boran, MD, 05052855844, ofboran@ksu.edu.tr
About this study
The aim of the study is to determine the psychometric properties of Perioperative Satisfaction Scale in Regional Anesthesia. In the Turkish version of the scale, a blind reverse translation method will use. And validity and reliability analyses will conduct.
Read the detailed description
The aim of the present research is to contribute to the international literature determining and describing the factor structure and psychometric qualities of the Perioperative Satisfaction Scale in Regional Anesthesia. An additional aim is to contribute to the national literature regarding the performance of the instrument in cross-cultural adaptation. The following steps will be taken: (a) translation of the scale from English into Turkish, (b) data collection, and (c) checking validity and reliability evidence for the adapted Perioperative Satisfaction Scale in Regional Anesthesia.
- Being tested
- Perioperative Satisfaction Scale in Regional Anesthesia
- Keywords
- scale, validity, reliability
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Satisfaction Scale in Regional AnesthesiaOther
Also called Measurement tool (Questionnaire)
This study is methodological research. Perioperative Satisfaction Scale in Regional Anesthesia will be used to collect data.
| Study group | Role | What they receive |
|---|---|---|
| Psycometric analyses | Other | It will be a validation study of the Perioperative Satisfaction Scale in Regional Anesthesia. This study is not experimental research. This is a psychometric assessment study of a questionnaire and data will collect pencil-paper survey and face to face from the patients who will get regional anesthesia in the postoperative second day. Receives: Other: Perioperative Satisfaction Scale in Regional Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Perioperative Satisfaction Scale in Regional Anesthesia will be applied, side effects such as nausea-vomiting, drowsiness will be noted. Patient satisfaction will be assessed with these methods as bad, medium, good, and very good.
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start20 Jun 2019
- Primary completion20 Feb 2020
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Scales, Repression-SensitizationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ömer Faruk Boran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ömer Faruk Boran, Kahramanmaras Sutcu Imam University
- Investigators
- Fatih Mehmet Yazar, MD, Study chair, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009018
- Sponsor's protocol ID
- Regional-1
- Status last verified
- Feb 2020
- First submitted
- 26 Jun 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mui WC, Chang CM, Cheng KF, Lee TY, Ng KO, Tsao KR, Hwang FM. Development and validation of the questionnaire of satisfaction with perioperative anesthetic care for general and regional anesthesia in Taiwanese patients. Anesthesiology. 2011 May;114(5):1064-75. doi: 10.1097/ALN.0b013e318216e835.
PubMed 21455058Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.
PubMed 23221859
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties
- ClinicalTrials.gov ID
- NCT04009018
- Acronym / sponsor ID
- Regional-1
- Keywords
- scale, validity, reliability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Ömer Faruk BoranUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 5 Jul 2019 (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.
The aim of the study is to determine the psychometric properties of Perioperative Satisfaction Scale in Regional Anesthesia. In the Turkish version of the scale, a blind reverse translation method will use. And validity and reliability analyses will conduct.
Detailed description
The aim of the present research is to contribute to the international literature determining and describing the factor structure and psychometric qualities of the Perioperative Satisfaction Scale in Regional Anesthesia. An additional aim is to contribute to the national literature regarding the performance of the instrument in cross-cultural adaptation. The following steps will be taken: (a) translation of the scale from English into Turkish, (b) data collection, and (c) checking validity and reliability evidence for the adapted Perioperative Satisfaction Scale in Regional Anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psycometric analyses | Other | Other: Perioperative Satisfaction Scale in Regional AnesthesiaIt will be a validation study of the Perioperative Satisfaction Scale in Regional Anesthesia. This study is not experimental research. This is a psychometric assessment study of a questionnaire and data will collect pencil-paper survey and face to face from the patients who will get regional anesthesia in the postoperative second day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteer to participate in the research
- Participants are over 18 years of age
- Provided regional anesthesia
- Postoperative second day
- No cognitive problems in self-expression
Key exclusion criteria (2 listed)
- Lack of Turkish literacy
- Use of anesthesia technique other than regional anesthesia
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 |
|---|---|---|
| Perioperative Satisfaction Scale in Regional AnesthesiaAlso: Measurement tool (Questionnaire)This study is methodological research. Perioperative Satisfaction Scale in Regional Anesthesia will be used to collect data. | Other | Psycometric analyses |
Primary outcome
Patient satisfaction
Time frame: postoperative 48 hours
Perioperative Satisfaction Scale in Regional Anesthesia will be applied, side effects such as nausea-vomiting, drowsiness will be noted. Patient satisfaction will be assessed with these methods as bad, medium, good, and very good.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 21455058Mui WC, Chang CM, Cheng KF, Lee TY, Ng KO, Tsao KR, Hwang FM. Development and validation of the questionnaire of satisfaction with perioperative anesthetic care for general and regional anesthesia in Taiwanese patients. Anesthesiology. 2011 May;114(5):1064-75. doi: 10.1097/ALN.0b013e318216e835.
- Results publication: PubMed 23221859Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.
- Original validation study of Perioperative Satisfaction Scale in Regional AnesthesiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Fatih Mehmet Yazar, MD study chair
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Satisfaction Scale in Regional Anesthesia in people with Scales, Repression-Sensitization and Anesthesia Awareness, run by Ömer Faruk Boran 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omer Faruk Boran, MD (05052855844, ofboran@ksu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: postoperative 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04009018, which also lists 2 linked publications.
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 20 Feb 2020.