AnxietyNCT05237557
Impact of an Operating Room Nurse Pre-operative Dialogue in Patients Undergoing Major Visceral Surgery
A study testing Preoperative nurse dialogue in people with Anxiety and Post Operative Pain, run by Nicolas DEMARTINES at 1 site in Switzerland.
Trial summary
Single-center, open label, randomized controlled trial of a preoperative nursing dialogue in patient undergoing major visceral surgery aiming in evaluating its impact on patients' anxiety, satisfaction and early postoperative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Post Operative Pain, Postoperative Nausea
- What is being tested?
- Preoperative nurse dialogue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jan 2020to 1 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing elective major visceral surgery
- Hospitalization the day before surgery
- Sufficient command of French language
Who cannot join
- emergency procedures (after unplanned admission)
- inability to obtain informed consent or refusal
- inability to follow intervention
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral Surgery, University Hospital CHUV, Lausanne
Lausanne, 1011
About this study
Official title: Impact of an Operating Room Nurse Pre-operative Dialogue on Anxiety, Satisfaction and Early Postoperative Outcomes in Patients Undergoing Major Visceral Surgery - a Single Center, Open-label, Randomized Controlled Trial
Single-center, open label, randomized controlled trial of a preoperative nursing dialogue in patient undergoing major visceral surgery aiming in evaluating its impact on patients' anxiety, satisfaction and early postoperative outcomes.
- Conditions
- Anxiety, Post Operative Pain, Postoperative Nausea, Postoperative Complications, Satisfaction, Patient
- Being tested
- Preoperative nurse dialogue
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative, Postoperative Nausea and Vomiting, Postoperative Complications, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative nurse dialogueBehavioural
Performance of a preoperative nurse dialogue prior major visceral surgery
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Not described Receives: Behavioral: Preoperative nurse dialogue |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety
State-Trait Anxiety Inventory Form Y (STAI-Y)
Measured: 5-10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start9 Jan 2020
- Primary completion29 Jun 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, Open-label, Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolas DEMARTINES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237557
- Sponsor's protocol ID
- 2022-00202
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Operating Room Nurse Pre-operative Dialogue on Anxiety, Satisfaction and Early Postoperative Outcomes in Patients Undergoing Major Visceral Surgery - a Single Center, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05237557
- Acronym / sponsor ID
- 2022-00202
- Conditions
- Anxiety, Post Operative Pain, Postoperative Nausea, Postoperative Complications, Satisfaction, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nicolas DEMARTINESUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 14 Feb 2022 (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.
Single-center, open label, randomized controlled trial of a preoperative nursing dialogue in patient undergoing major visceral surgery aiming in evaluating its impact on patients' anxiety, satisfaction and early postoperative outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, Open-label, Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: Preoperative nurse dialogue |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient undergoing elective major visceral surgery
- Hospitalization the day before surgery
- Sufficient command of French language
Key exclusion criteria (3 listed)
- emergency procedures (after unplanned admission)
- inability to obtain informed consent or refusal
- inability to follow intervention
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 |
|---|---|---|
| Preoperative nurse dialoguePerformance of a preoperative nurse dialogue prior major visceral surgery | Behavioural | Interventional group |
Primary outcome
Preoperative anxiety
Time frame: 5-10 minutes after intervention
State-Trait Anxiety Inventory Form Y (STAI-Y)
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 2 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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 Preoperative nurse dialogue in people with Anxiety and Post Operative Pain, run by Nicolas DEMARTINES at 1 site in Switzerland.
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 3 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 2 Mar 2022. 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 Switzerland. 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?
Preoperative anxiety (time frame: 5-10 minutes after intervention). 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 2 Mar 2022.