NCT03327506

Brief Summary

The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 27, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

October 17, 2017

Last Update Submit

February 22, 2021

Conditions

Gynecologic DiseaseAnxiety Disease

Keywords

Premedication/ Hypnosis/ Anxiety/Surgery

Outcome Measures

Primary Outcomes (1)

  • Preoperative Anxiety score evaluated by STAI-Y

    evaluated by STAI-Y self-administered questionary

    before surgery (day 2_before)

Secondary Outcomes (8)

  • Anxiety score evaluated by analogue visual scale

    at inclusion visit (day 1), before surgery (day 2_before), after surgery (day 2_after), 24 h after the surgery (day 3)

  • sleep quality evaluated by EVA scale

    day 2_before and the day 3

  • patient satisfaction score evaluated by EVA scale

    day 3

  • analysis of salivary amylase

    day 1 and day2_before

  • postoperative fatigue evaluated by EVA scale

    day 3

  • +3 more secondary outcomes

Study Arms (2)

hypnosis group

EXPERIMENTAL

Intervention: hypnosis session the eve of the surgery

Drug: Alprazolam 0.5 mg

premedication

ACTIVE COMPARATOR

alprazolam 0,5 mg the eve and the morning of the surgery

Drug: Alprazolam 0.5 mg

Interventions

Alprazolam 0.5 mgDRUG

alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session

Also known as: hypnosis
hypnosis grouppremedication

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient's age: over 18 years
  • Patient care and follow-up at the regional maternity center of Nancy (CHRU of Nancy)
  • Female patient for whom gynecological laparoscopic surgery is programmed and lasting longer than 1 hour (ovarian cyst, laparoscopy infertility, laparoscopic promontofixation, noncarcinogenic assisted laparoscopy hysterectomy, endometriosis, diagnostic laparoscopy, pyosalpinx, hydrosalpinx)
  • Patient with Physical status score (ASA) score between 1 and 3
  • With standardized anesthesia protocol
  • Patient affiliated to a Social Security
  • Patient has received complete information about the organization of the research and has signed her informed consent

You may not qualify if:

  • Pretreatment by benzodiazepines
  • Known hypersensitivity to Alprazolam® (including undocumented)
  • Prohibition conditions to Alprazolam®: Severe respiratory insufficiency, Sleep apnea syndrome, Myasthenia, Severe acute or chronic hepatic impairment
  • Ongoing major depressive episode
  • Chronic use (\> 1 month) of benzodiazepines or morphine or analgesics of level 2
  • Patient referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florence Vial

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

AlprazolamHypnosis

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

florence vial

CONTACT

0033610405237f.vial@chu-nancy.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 31, 2017

Study Start

November 27, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

FR(1)