Kidney TransplantationNCT03131258
The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy
A study testing Donor Nephrectomy in people with Kidney Transplantation and Anxiety, run by Ege University.
Trial summary
Kidney transplant is the most effective choice of treatment for patients with end-stage kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney transplantations are implemented with living donors. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Transplantation, Anxiety, Pain, Acute
- What is being tested?
- Donor Nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jan 2016
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II between 18-60 years
- Donor Nephrectomy patients
Who cannot join
- psychiatric disturbance
- medicinal allergy
About this study
Kidney transplant is the most effective choice of treatment for patients with end-stage kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney transplantations are implemented with living donors.
Donor nephrectomy is an operations which has the end goal of a living donor donating one of his kidneys to a patient with end-stage kidney failure (1).
Read more
Pre-operative anxiety is a condition which is characterized by a random illness, being hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is to be experienced. Educating and informing in the pre-operative period is the first step in mentally preparing the patient for the operation. In some studies, it has been pointed out that patients who were thoroughly informed in the pre-operative period have lower anxiety levels both in the pre-operative and post-operative periods with also less levels of pain and increased recovery rates in the latter (2).
Anesthetic recovery starts at the end of the surgical process and ends with the anesthetized patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle strength.
Post-operative pain is acute pain which starts with surgical trauma and ends with tissue healing (3). Providing optimal post-operative analgesia plays an important role in the prevention of post-operative complications (1,4,5).
There are studies which examine the link between pre-operative anxiety and post-operative pain (59,74,74,77,78). Patients who will undergo a donor nephrectomy constitute a specific group of patients both because they are not operated due to a health problem that they have and because the operation results with them losing an organ. There are no prospective studies about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in individuals who have undergone donor nephrectomy in literature. Because of this, we have aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in patients that were to undergo donor nephrectomy surgery.
- Being tested
- Donor Nephrectomy
- Medical subject headings
- Anxiety Disorders, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor NephrectomyProcedure or surgery
48 Donor Nephrectomy Patients
| Study group | Role | What they receive |
|---|---|---|
| Donor Nephrectomy | Other | Donor Nephrectomy Receives: Procedure: Donor Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Patient's pain intensity as measured by visual analogue scale
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study startJun 2014
- Primary completionJun 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Ege 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERBIL TURKSAL, Ege University
- Investigators
- Erbil Türksal, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131258
- Sponsor's protocol ID
- 14-5.1/5
- Status last verified
- Apr 2017
- First submitted
- 10 Feb 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy
- ClinicalTrials.gov ID
- NCT03131258
- Acronym / sponsor ID
- 14-5.1/5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Apr 2017 (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.
Kidney transplant is the most effective choice of treatment for patients with end-stage kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney transplantations are implemented with living donors.
Donor nephrectomy is an operations which has the end goal of a living donor donating one of his kidneys to a patient with end-stage kidney failure (1).
Pre-operative anxiety is a condition which is characterized by a random illness, being hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is to be experienced. Educating and informing in the pre-operative period is the first step in mentally preparing the patient for the operation. In some studies, it has been pointed out that patients who were thoroughly informed in the pre-operative period have lower anxiety levels both in the pre-operative and post-operative periods with also less levels of pain and increased recovery rates in the latter (2).
Anesthetic recovery starts at the end of the surgical process and ends with the anesthetized patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle strength.
Post-operative pain is acute pain which starts with surgical trauma and ends with tissue healing (3). Providing optimal post-operative analgesia plays an important role in the prevention of post-operative complications (1,4,5).
There are studies which examine the link between pre-operative anxiety and post-operative pain (59,74,74,77,78). Patients who will undergo a donor nephrectomy constitute a specific group of patients both because they are not operated due to a health problem that they have and because the operation results with them losing an organ. There are no prospective studies about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in individuals who have undergone donor nephrectomy in literature. Because of this, we have aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in patients that were to undergo donor nephrectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donor Nephrectomy | Other | Procedure: Donor NephrectomyDonor Nephrectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I-II between 18-60 years
- Donor Nephrectomy patients
Key exclusion criteria (2 listed)
- psychiatric disturbance
- medicinal allergy
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 |
|---|---|---|
| Donor Nephrectomy48 Donor Nephrectomy Patients | Procedure or surgery | Donor Nephrectomy |
Primary outcome
Postoperative Pain Intensity
Time frame: 48 hours
Patient's pain intensity as measured by visual analogue scale
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 27 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
Erbil Türksal, MD principal investigator
Ege University
Questions about this trial
What is this clinical trial studying?
A study testing Donor Nephrectomy in people with Kidney Transplantation and Anxiety, run by Ege University.
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 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: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative Pain Intensity (time frame: 48 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 27 Apr 2017.