AnxietyNCT04432558

Postoperative Effects of Preoperative Anxiety

An observational study of Anxiety and Pain, Postoperative, run by Baskent University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Anxiety, Pain, Postoperative
What is being tested?: Spielberger's State-Trait Anxiety Inventory, Visual analog scale, Ramsay's sedation scale and Tramadol, paracetamol, diclofenac sodium
How many people: 42 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 12 Apr 2017to 30 Jan 2021
How long will I take part?: 1 Day
Phase: Observational
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
Healthy volunteers accepted
Adult, Older adult

Study population: Female patients aged between 18-65 years old, ASA I-II, which BMI ≥35 kg/m^2 and have bariatric surgical indications because of morbid (type III) obesity

Who may be able to join

Female patients aged between 18-65 years old
ASA I-II
BMI ≥35 kg/m^2

Who cannot join

Having a psychiatric or neurologic disease
Brain damage
Using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol
Known allergy to medications used in the study protocol

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Baskent University Zubeyde Hanim Practice and Research Center
Izmir, Karşıyaka, 35540

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Preoperative Anxiety Level to Postoperative Pain and Analgesic Consumption in Patients Who Had Laparoscopic Sleeve Gastrectomy

INTRODUCTION Patients who will have obesity surgery have about %48 psychiatric illnesses like anxiety disorder. Studies which analyze the relationship between preoperative anxiety level and postoperative pain had reported conflicting results. The aim of this study is to search the relationship between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy surgery.

MATERIAL AND METHODS Our prospective double-blind study is planned to require 86 female patients aged between 18-65 years old, American Society of Anesthesiologists (ASA) I-II and Body mass index (BMI) ≥40 kg/m^2. Patients having a psychiatric or neurologic disease, brain damage, using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol, known allergy to medications used in the study protocol, inability to provide informed consent will be excluded. Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery. The analgesic consumption of the patients will be recorded by evaluating the pain with Visual analog scale (VAS) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.

EXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS More satisfying postoperative analgesia may be provided in this group of patients by determining correlation between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy. Morbidity rate related with pain may be decreased and patient satisfaction may be increased.

Conditions: Anxiety, Pain, Postoperative
Being tested: Spielberger's State-Trait Anxiety Inventory, Visual analog scale, Ramsay's sedation scale, Tramadol, paracetamol, diclofenac sodium
Keywords: Preoperative anxiety level, Postoperative pain, Laparoscopic sleeve gastrectomy
Medical subject headings: Anxiety Disorders, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spielberger's State-Trait Anxiety InventoryDiagnostic test
Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery.
Visual analog scale, Ramsay's sedation scaleOther
The analgesic consumption of the patients will be recorded by evaluating the pain with VAS (Visual analog scale) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.
Tramadol, paracetamol, diclofenac sodiumDrug
The analgesic consumption of the patients will be recorded

Study groups in NCT04432558
Study group	Role	What they receive
Preoperative anxiety level		Not described Receives: Diagnostic Test: Spielberger's State-Trait Anxiety Inventory
Postoperative pain and analgesic consumption		Not described Receives: Other: Visual analog scale, Ramsay's sedation scale; Drug: Tramadol, paracetamol, diclofenac sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

Does Preoperative anxiety level effect postoperative pain?
More satisfying postoperative analgesia may be provided in this group of patients by determining correlation between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy.Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery. The analgesic consumption of the patients will be recorded by evaluating the pain with Visual analog scale (VAS) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 201730 Jan 2021

First posted16 Jun 2020
Study start12 Apr 2017
Primary completion31 Dec 2020
Study completion30 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 42 participants (actual)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT04432558
Sponsor's protocol ID: K17/24
Status last verified: Jul 2021
First submitted: 5 Jun 2020
Last updated: 21 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Jawaid M, Mushtaq A, Mukhtar S, Khan Z. Preoperative anxiety before elective surgery. Neurosciences (Riyadh). 2007 Apr;12(2):145-8.
PubMed 21857597
Akinsulore A, Owojuyigbe AM, Faponle AF, Fatoye FO. ASSESSMENT OF PREOPERATIVE AND POSTOPERATIVE ANXIETY AMONG ELECTIVE MAJOR SURGERY PATIENTS IN A TERTIARY HOSPITAL IN NIGERIA. Middle East J Anaesthesiol. 2015 Jun;23(2):235-40.
PubMed 26442401
de Zwaan M, Enderle J, Wagner S, Muhlhans B, Ditzen B, Gefeller O, Mitchell JE, Muller A. Anxiety and depression in bariatric surgery patients: a prospective, follow-up study using structured clinical interviews. J Affect Disord. 2011 Sep;133(1-2):61-8. doi: 10.1016/j.jad.2011.03.025. Epub 2011 Apr 17.
PubMed 21501874
Edwards-Hampton SA, Madan A, Wedin S, Borckardt JJ, Crowley N, Byrne KT. A closer look at the nature of anxiety in weight loss surgery candidates. Int J Psychiatry Med. 2014;47(2):105-13. doi: 10.2190/PM.47.2.b.
PubMed 25084797
Clarke H, Kirkham KR, Orser BA, Katznelson R, Mitsakakis N, Ko R, Snyman A, Ma M, Katz J. Gabapentin reduces preoperative anxiety and pain catastrophizing in highly anxious patients prior to major surgery: a blinded randomized placebo-controlled trial. Can J Anaesth. 2013 May;60(5):432-43. doi: 10.1007/s12630-013-9890-1. Epub 2013 Feb 2.
PubMed 23377862
Robleda G, Sillero-Sillero A, Puig T, Gich I, Banos JE. Influence of preoperative emotional state on postoperative pain following orthopedic and trauma surgery. Rev Lat Am Enfermagem. 2014 Oct;22(5):785-91. doi: 10.1590/0104-1169.0118.2481.
PubMed 25493674
Raichle KA, Osborne TL, Jensen MP, Ehde DM, Smith DG, Robinson LR. Preoperative state anxiety, acute postoperative pain, and analgesic use in persons undergoing lower limb amputation. Clin J Pain. 2015 Aug;31(8):699-706. doi: 10.1097/AJP.0000000000000150.
PubMed 26153780
Petrovic NM, Milovanovic DR, Ignjatovic Ristic D, Riznic N, Ristic B, Stepanovic Z. Factors associated with severe postoperative pain in patients with total hip arthroplasty. Acta Orthop Traumatol Turc. 2014;48(6):615-22. doi: 10.3944/AOTT.2014.14.0177.
PubMed 25637724
Ali A, Altun D, Oguz BH, Ilhan M, Demircan F, Koltka K. The effect of preoperative anxiety on postoperative analgesia and anesthesia recovery in patients undergoing laparascopic cholecystectomy. J Anesth. 2014 Apr;28(2):222-7. doi: 10.1007/s00540-013-1712-7. No abstract available.
PubMed 24077858
Aouad MT, Kanazi GE, Malek K, Tamim H, Zahreddine L, Kaddoum RN. Predictors of postoperative pain and analgesic requirements following abdominal hysterectomy: an observational study. J Anesth. 2016 Feb;30(1):72-9. doi: 10.1007/s00540-015-2090-0. Epub 2015 Oct 24.
PubMed 26499321
Bradshaw P, Hariharan S, Chen D. Does preoperative psychological status of patients affect postoperative pain? A prospective study from the Caribbean. Br J Pain. 2016 May;10(2):108-15. doi: 10.1177/2049463716635680. Epub 2016 Mar 2.
PubMed 27551421
De Cosmo G, Congedo E, Lai C, Primieri P, Dottarelli A, Aceto P. Preoperative psychologic and demographic predictors of pain perception and tramadol consumption using intravenous patient-controlled analgesia. Clin J Pain. 2008 Jun;24(5):399-405. doi: 10.1097/AJP.0b013e3181671a08.
PubMed 18496304
Kain ZN, Sevarino F, Alexander GM, Pincus S, Mayes LC. Preoperative anxiety and postoperative pain in women undergoing hysterectomy. A repeated-measures design. J Psychosom Res. 2000 Dec;49(6):417-22. doi: 10.1016/s0022-3999(00)00189-6.
PubMed 11182434
Polomano RC, Heffner SM, Reck DL, Gelnett CM, French D. Evidence for opioid variability, Part 2: Psychosocial influences. Semin Perioper Nurs. 2001 Oct;10(4):159-66.
PubMed 15129613
Caumo W, Hidalgo MP, Schmidt AP, Iwamoto CW, Adamatti LC, Bergmann J, Ferreira MB. Effect of pre-operative anxiolysis on postoperative pain response in patients undergoing total abdominal hysterectomy. Anaesthesia. 2002 Aug;57(8):740-6. doi: 10.1046/j.1365-2044.2002.02690.x.
PubMed 12133084

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Preoperative Anxiety Level to Postoperative Pain and Analgesic Consumption in Patients Who Had Laparoscopic Sleeve Gastrectomy
ClinicalTrials.gov ID: NCT04432558
Acronym / sponsor ID: K17/24
Conditions: Anxiety, Pain, Postoperative
Keywords: Preoperative anxiety level, Postoperative pain, Laparoscopic sleeve gastrectomy
Study type: Observational
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Baskent UniversityUniversity, hospital or other
Study start: 12 Apr 2017 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 30 Jan 2021 (actual)
First posted: 16 Jun 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.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Day
Number of arms: 2

Arm	Type	Receives
Preoperative anxiety level	–	Diagnostic Test: Spielberger's State-Trait Anxiety Inventory
Postoperative pain and analgesic consumption	–	Other: Visual analog scale, Ramsay's sedation scale, Drug: Tramadol, paracetamol, diclofenac sodium

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Female patients aged between 18-65 years old, ASA I-II, which BMI ≥35 kg/m^2 and have bariatric surgical indications because of morbid (type III) obesity

Key inclusion criteria (3 listed)

Female patients aged between 18-65 years old
ASA I-II
BMI ≥35 kg/m^2

Key exclusion criteria (4 listed)

Having a psychiatric or neurologic disease
Brain damage
Using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol
Known allergy to medications used in the study protocol

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
Spielberger's State-Trait Anxiety InventoryPatients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery.	Diagnostic test	Preoperative anxiety level
Visual analog scale, Ramsay's sedation scaleThe analgesic consumption of the patients will be recorded by evaluating the pain with VAS (Visual analog scale) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.	Other	Postoperative pain and analgesic consumption
Tramadol, paracetamol, diclofenac sodiumThe analgesic consumption of the patients will be recorded	Drug	Postoperative pain and analgesic consumption

Primary outcome

Does Preoperative anxiety level effect postoperative pain?
Time frame: 5 years
More satisfying postoperative analgesia may be provided in this group of patients by determining correlation between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy.Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery. The analgesic consumption of the patients will be recorded by evaluating the pain with Visual analog scale (VAS) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.

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 21 Jul 2021.
Background: PubMed 21857597Jawaid M, Mushtaq A, Mukhtar S, Khan Z. Preoperative anxiety before elective surgery. Neurosciences (Riyadh). 2007 Apr;12(2):145-8.
Background: PubMed 26442401Akinsulore A, Owojuyigbe AM, Faponle AF, Fatoye FO. ASSESSMENT OF PREOPERATIVE AND POSTOPERATIVE ANXIETY AMONG ELECTIVE MAJOR SURGERY PATIENTS IN A TERTIARY HOSPITAL IN NIGERIA. Middle East J Anaesthesiol. 2015 Jun;23(2):235-40.
Background: PubMed 21501874de Zwaan M, Enderle J, Wagner S, Muhlhans B, Ditzen B, Gefeller O, Mitchell JE, Muller A. Anxiety and depression in bariatric surgery patients: a prospective, follow-up study using structured clinical interviews. J Affect Disord. 2011 Sep;133(1-2):61-8. doi: 10.1016/j.jad.2011.03.025. Epub 2011 Apr 17.
Background: PubMed 25084797Edwards-Hampton SA, Madan A, Wedin S, Borckardt JJ, Crowley N, Byrne KT. A closer look at the nature of anxiety in weight loss surgery candidates. Int J Psychiatry Med. 2014;47(2):105-13. doi: 10.2190/PM.47.2.b.
Background: PubMed 23377862Clarke H, Kirkham KR, Orser BA, Katznelson R, Mitsakakis N, Ko R, Snyman A, Ma M, Katz J. Gabapentin reduces preoperative anxiety and pain catastrophizing in highly anxious patients prior to major surgery: a blinded randomized placebo-controlled trial. Can J Anaesth. 2013 May;60(5):432-43. doi: 10.1007/s12630-013-9890-1. Epub 2013 Feb 2.
Background: PubMed 25493674Robleda G, Sillero-Sillero A, Puig T, Gich I, Banos JE. Influence of preoperative emotional state on postoperative pain following orthopedic and trauma surgery. Rev Lat Am Enfermagem. 2014 Oct;22(5):785-91. doi: 10.1590/0104-1169.0118.2481.
Background: PubMed 26153780Raichle KA, Osborne TL, Jensen MP, Ehde DM, Smith DG, Robinson LR. Preoperative state anxiety, acute postoperative pain, and analgesic use in persons undergoing lower limb amputation. Clin J Pain. 2015 Aug;31(8):699-706. doi: 10.1097/AJP.0000000000000150.
Background: PubMed 25637724Petrovic NM, Milovanovic DR, Ignjatovic Ristic D, Riznic N, Ristic B, Stepanovic Z. Factors associated with severe postoperative pain in patients with total hip arthroplasty. Acta Orthop Traumatol Turc. 2014;48(6):615-22. doi: 10.3944/AOTT.2014.14.0177.
Background: PubMed 24077858Ali A, Altun D, Oguz BH, Ilhan M, Demircan F, Koltka K. The effect of preoperative anxiety on postoperative analgesia and anesthesia recovery in patients undergoing laparascopic cholecystectomy. J Anesth. 2014 Apr;28(2):222-7. doi: 10.1007/s00540-013-1712-7. No abstract available.
Background: PubMed 26499321Aouad MT, Kanazi GE, Malek K, Tamim H, Zahreddine L, Kaddoum RN. Predictors of postoperative pain and analgesic requirements following abdominal hysterectomy: an observational study. J Anesth. 2016 Feb;30(1):72-9. doi: 10.1007/s00540-015-2090-0. Epub 2015 Oct 24.
Background: PubMed 27551421Bradshaw P, Hariharan S, Chen D. Does preoperative psychological status of patients affect postoperative pain? A prospective study from the Caribbean. Br J Pain. 2016 May;10(2):108-15. doi: 10.1177/2049463716635680. Epub 2016 Mar 2.
Background: PubMed 18496304De Cosmo G, Congedo E, Lai C, Primieri P, Dottarelli A, Aceto P. Preoperative psychologic and demographic predictors of pain perception and tramadol consumption using intravenous patient-controlled analgesia. Clin J Pain. 2008 Jun;24(5):399-405. doi: 10.1097/AJP.0b013e3181671a08.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anxiety and Pain, Postoperative, run by Baskent 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 3 inclusion and 4 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 21 Jul 2021. 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?

Does Preoperative anxiety level effect postoperative pain? (time frame: 5 years). 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 NCT04432558, which also lists 28 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 21 Jul 2021.