Postoperative CareNCT03807960
Information for Patient Controlled Analgesia Device
A study testing written form, video and routine care in people with Postoperative Care and Hysterectomy, run by Tuğba Karaman at 1 site in Turkey (Türkiye).
Trial summary
This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Care, Hysterectomy, Health Communication
- What is being tested?
- written form, video and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 21 Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- Elective hysterectomy
Who cannot join
- Opioid abuse or Chronic opioid usage
- opioid allergy
- obesity(BMI>30)
- psychiatric disease
- more than American Anesthesiologist Score 2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Hospital
Tokat Province, Merkez, 60100
About this study
Official title: The Effect of Visual and Written Information Tools on Patient Controlled Analgesia Device Usage
This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device
Read the detailed description
Postoperative pain is still a challenge for anesthesiologist. Patient controlled analgesia is an effective method for postoperative pain management. However, most of the patient can not use the device properly. The important cause of inabilities about device usage is insufficient information.In the patient information, visual, oral or written communication methods can be chosen. However, which method is suitable for our patient group is not clear.This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device
- Conditions
- Postoperative Care, Hysterectomy, Health Communication
- Being tested
- written form, video, routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
written formOther
The written form which include PCA usage information.
videoOther
The video about PCA usage
routine careOther
The routine description about PCA usage
| Study group | Role | What they receive |
|---|---|---|
| visual | Experimental | The video about patient controlled analgesia device (PCA) usage will shown to the patients via notebook. Receives: Other: video |
| written | Experimental | The written form which include the same knowledge will give to the patient for reading. Receives: Other: written form |
| control | Other | The anesthesiologist will describe the PCA usage as in the routine care to the control group patients. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Numeric rating scale (0 to 10) will be used for postoperative pain score
Measured: At postoperative 24th hours.
Secondary outcomes (5)
Postoperative analgesic consumption
Total opioid dosage will be recorded
Measured: Up to the postoperative 24th hours.
PCA device usage
The number of demand dose
Measured: During postoperative 24 hours
PCA device demand dose duration
The duration of the patients' demanding dose
Measured: During postoperative 24hours
Patient's satisfaction
The numeric rating scale (0 to 10) will be used. In this scale 0 will be the worst, 10 will be the best satisfaction.
Measured: At the postoperative 24th hours
The change of the postoperative pain score
Numeric rating scale (0 to 10) will be used to evaluate the pain score. The change in this score during postoperative 24 hours will be calculated.(the first score will be extracted from the last score)
Measured: Up to the postoperative 24th hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Feb 2019
- Primary completion20 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuğba Karaman
- Sponsor type
- University, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Responsible party
- Sponsor-investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
- Investigators
- Serkan Karaman, MD, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807960
- Sponsor's protocol ID
- pcı
- Status last verified
- Jul 2019
- First submitted
- 11 Jan 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visual and Written Information Tools on Patient Controlled Analgesia Device Usage
- ClinicalTrials.gov ID
- NCT03807960
- Acronym / sponsor ID
- pcı
- Conditions
- Postoperative Care, Hysterectomy, Health Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tuğba KaramanUniversity, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 17 Jan 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.
This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device
Detailed description
Postoperative pain is still a challenge for anesthesiologist. Patient controlled analgesia is an effective method for postoperative pain management. However, most of the patient can not use the device properly. The important cause of inabilities about device usage is insufficient information.In the patient information, visual, oral or written communication methods can be chosen. However, which method is suitable for our patient group is not clear.This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| visual | Experimental | Other: videoThe video about patient controlled analgesia device (PCA) usage will shown to the patients via notebook. |
| written | Experimental | Other: written formThe written form which include the same knowledge will give to the patient for reading. |
| control | Other | Other: routine careThe anesthesiologist will describe the PCA usage as in the routine care to the control group patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- informed consent
- Elective hysterectomy
Key exclusion criteria (5 listed)
- Opioid abuse or Chronic opioid usage
- opioid allergy
- obesity(BMI>30)
- psychiatric disease
- more than American Anesthesiologist Score 2
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 |
|---|---|---|
| written formThe written form which include PCA usage information. | Other | written |
| videoThe video about PCA usage | Other | visual |
| routine careThe routine description about PCA usage | Other | control |
Primary outcome
Pain Score
Time frame: At postoperative 24th hours.
Numeric rating scale (0 to 10) will be used for postoperative pain score
5 secondary outcomes
Postoperative analgesic consumption
Time frame: Up to the postoperative 24th hours.
PCA device usage
Time frame: During postoperative 24 hours
PCA device demand dose duration
Time frame: During postoperative 24hours
Patient's satisfaction
Time frame: At the postoperative 24th hours
The change of the postoperative pain score
Time frame: Up to the postoperative 24th hours.
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 8 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Serkan Karaman, MD principal investigator
Gaziosmanpasa 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 written form, video and routine care in people with Postoperative Care and Hysterectomy, run by Tuğba Karaman 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 2 inclusion and 5 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 8 Jul 2019. 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?
Pain Score (time frame: At postoperative 24th hours.). 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 8 Jul 2019.