AnxietyNCT02938845
Does Minimally Invasive Surgery Reduce Anxiety?
A study testing Spielberger's State-Trait Anxiety Inventory(STAI ), total laparoscopic hysterectomy(TLH) and total abdominal hysterectomy(TAH) in people with Anxiety, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to identify factors that may contribute to anxiety of patients undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before and after the operation. Thus, we aimed to learn whether anxiety levels change according to the type of hysterectomy. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Spielberger's State-Trait Anxiety Inventory(STAI ), total laparoscopic hysterectomy(TLH) and total abdominal hysterectomy(TAH)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Dec 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergone hysterectomies for benign reasons.
Who cannot join
- malignancy, additional operation beside hysterectomy( such as salpingo-oophorectomy), history of two or more previous caesarean sections, history of previous abdominal surgery, autoimmune disease, coagulation disorders, with known systemic or psychiatric disease, those receiving any regular sedative medication at the time of the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Woman and Child Diseases Education and Research Hospital
Istanbul, 34000
About this study
Official title: Factors Related to Patients' Anxiety Before and After Hysterectomy
The purpose of this study was to identify factors that may contribute to anxiety of patients undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before and after the operation. Thus, we aimed to learn whether anxiety levels change according to the type of hysterectomy.
Read the detailed description
Hysterectomy is the most common gynecological procedure worldwide. . There has been a increasing interest towards to more minimally invasive procedures in the past decade. Hysterectomy operation anxiety is a complex phenomenon affected by various parameters. Patients' anxiety may be affected by their age, gender, educational status,type of operation and personality. Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.
- Conditions
- Anxiety
- Being tested
- Spielberger's State-Trait Anxiety Inventory(STAI ), total laparoscopic hysterectomy(TLH), total abdominal hysterectomy(TAH)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spielberger's State-Trait Anxiety Inventory(STAI )Behavioural
State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation, whereas trait anxiety (STAI-T) represents anxiety as a relatively stable personality character. Each scale has values ranging from 20 to 80, with higher scores representing more severe anxiety. The STAI has no established categories, but a cutoff score of 40 has been used to identify patients with high/very high anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.
total laparoscopic hysterectomy(TLH)Procedure or surgery
total abdominal hysterectomy(TAH)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| total laparoscopic hysterectomy(TLH) | Experimental | Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation. Receives: Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI ); Procedure: total laparoscopic hysterectomy(TLH) |
| total abdominal hysterectomy(TAH) | Experimental | Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation. Receives: Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI ); Procedure: total abdominal hysterectomy(TAH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAI-S's Inventory
Measured: change from immediately before operation to immediately after the operation.
STAI-T's Inventory
Measured: change from immediately before operation to immediately after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938845
- Sponsor's protocol ID
- 025
- Status last verified
- Dec 2016
- First submitted
- 12 Oct 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Lopez-Jornet P, Camacho-Alonso F, Sanchez-Siles M. Assessment of general pre and postoperative anxiety in patients undergoing tooth extraction: a prospective study. Br J Oral Maxillofac Surg. 2014 Jan;52(1):18-23. doi: 10.1016/j.bjoms.2013.01.004. Epub 2013 Jan 26.
PubMed 23357053Muglali M, Komerik N. Factors related to patients' anxiety before and after oral surgery. J Oral Maxillofac Surg. 2008 May;66(5):870-7. doi: 10.1016/j.joms.2007.06.662.
PubMed 18423273Flory N, Bissonnette F, Binik YM. Psychosocial effects of hysterectomy: literature review. J Psychosom Res. 2005 Sep;59(3):117-29. doi: 10.1016/j.jpsychores.2005.05.009.
PubMed 16198184
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Related to Patients' Anxiety Before and After Hysterectomy
- ClinicalTrials.gov ID
- NCT02938845
- Acronym / sponsor ID
- 025
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Oct 2016 (estimated)
- 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 purpose of this study was to identify factors that may contribute to anxiety of patients undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before and after the operation. Thus, we aimed to learn whether anxiety levels change according to the type of hysterectomy.
Detailed description
Hysterectomy is the most common gynecological procedure worldwide. . There has been a increasing interest towards to more minimally invasive procedures in the past decade. Hysterectomy operation anxiety is a complex phenomenon affected by various parameters. Patients' anxiety may be affected by their age, gender, educational status,type of operation and personality. Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total laparoscopic hysterectomy(TLH) | Experimental | Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI ), Procedure: total laparoscopic hysterectomy(TLH)Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation. |
| total abdominal hysterectomy(TAH) | Experimental | Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI ), Procedure: total abdominal hysterectomy(TAH)Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergone hysterectomies for benign reasons.
Key exclusion criteria (1 listed)
- malignancy, additional operation beside hysterectomy( such as salpingo-oophorectomy), history of two or more previous caesarean sections, history of previous abdominal surgery, autoimmune disease, coagulation disorders, with known systemic or psychiatric disease, those receiving any regular sedative medication at the time of the procedure
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 Inventory(STAI )State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation, whereas trait anxiety (STAI-T) represents anxiety as a relatively stable personality character. Each scale has values ranging from 20 to 80, with higher scores representing more severe anxiety. The STAI has no established categories, but a cutoff score of 40 has been used to identify patients with high/very high anxiety. The validity and reliability of the Turkish versions of these instruments have been validated. | Behavioural | total abdominal hysterectomy(TAH), total laparoscopic hysterectomy(TLH) |
| total laparoscopic hysterectomy(TLH) | Procedure or surgery | total laparoscopic hysterectomy(TLH) |
| total abdominal hysterectomy(TAH) | Procedure or surgery | total abdominal hysterectomy(TAH) |
Primary outcome
STAI-S's Inventory
Time frame: change from immediately before operation to immediately after the operation.
STAI-T's Inventory
Time frame: change from immediately before operation to immediately after the operation.
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 Dec 2016.
- Results publication: PubMed 23357053Lopez-Jornet P, Camacho-Alonso F, Sanchez-Siles M. Assessment of general pre and postoperative anxiety in patients undergoing tooth extraction: a prospective study. Br J Oral Maxillofac Surg. 2014 Jan;52(1):18-23. doi: 10.1016/j.bjoms.2013.01.004. Epub 2013 Jan 26.
- Results publication: PubMed 18423273Muglali M, Komerik N. Factors related to patients' anxiety before and after oral surgery. J Oral Maxillofac Surg. 2008 May;66(5):870-7. doi: 10.1016/j.joms.2007.06.662.
- Results publication: PubMed 16198184Flory N, Bissonnette F, Binik YM. Psychosocial effects of hysterectomy: literature review. J Psychosom Res. 2005 Sep;59(3):117-29. doi: 10.1016/j.jpsychores.2005.05.009.
- Individual participant dataSharing planned: Yes
Related trials for Anxiety
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
Anxiety
Not yet recruiting
Music for Reducing Anxiety Before Surgery
Preoperative Anxiety
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
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?
A study testing Spielberger's State-Trait Anxiety Inventory(STAI ), total laparoscopic hysterectomy(TLH) and total abdominal hysterectomy(TAH) in people with Anxiety, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital 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 1 inclusion and 1 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 Dec 2016. 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?
STAI-S's Inventory (time frame: change from immediately before operation to immediately after the operation.). 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?
On the ClinicalTrials.gov record for NCT02938845, which also lists 3 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 8 Dec 2016.