AnxietyNCT04829266
Mental Simulations and Early Mobilization of Patients After Cesarean Section
A study testing mental simulation in people with Anxiety and Cesarean Section, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Mental simulations can motivate patients for their first verticalization after cesarean section, although perceived anxiety before verticalization may reduce a positive effect of mental simulations. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Cesarean Section
- What is being tested?
- mental simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 15 Dec 2017to 27 May 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- must be qualified to and undergoing delivery using Cesarean section,
- must be undergoing conduction of anesthesia during Cesarean section,
- must be undergoing the analgesic therapy in the postoperative period,
- must be qualified to mobilization by the medical staff,
- must be fluent in Polish in speaking and writing.
Who cannot join
- any orthopedic dysfunction,
- any neurological dysfunction,
- any psychiatric disease.
Trial locations and contacts
1 site in 1 country.
Poland1 site
2nd Chair and Clinic of Gynecology and Obstetrics, Jan Mikulicz-Radecki University Teaching Hospital in Wrocław, Wrocław, Poland
Wroclaw, 50-556
About this study
Official title: Effect of Mental Simulations on the Early Mobilization of Patients After Cesarean Section
Mental simulations can motivate patients for their first verticalization after cesarean section, although perceived anxiety before verticalization may reduce a positive effect of mental simulations.
- Conditions
- Anxiety, Cesarean Section
- Being tested
- mental simulation
- Keywords
- mental simulation, anxiety, verticalization, obstetrics, cesarean section, post-operative care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mental simulationBehavioural
Also called The recording of the process simulation included the order to imagine subsequent elements of the process of mobilization., The recording of the outcome simulation included an optimistic vision of returning to health and fitness., A fragment of the book "Little Prince" by Antoine de Saint-Exupéry, including an order to imagine the elements of the world as seen through the eyes of the main character
Audio recordings with a mental simulation. The women listened to the text using headphones about 10-15 min before verticalization (5 h after arrival in the postoperative room, about 6 h after anesthesia). In each group, the mental training lasted for about 10 min.
| Study group | Role | What they receive |
|---|---|---|
| process simulation group | Experimental | an experimental group with process simulation with elements of relaxation Receives: Behavioral: mental simulation |
| outcome simulation group | Experimental | an experimental group with outcome simulation with elements of relaxation Receives: Behavioral: mental simulation |
| control group | Other | a control group with no process and outcome simulations, but with elements of relaxation Receives: Behavioral: mental simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
willingness to verticalize
Percentage of women who were willing to verticalize after listening to the recording. Assessed on a on a six-point scale.
Measured: Immediately after a single mental simulation
verticalization
Percentage of the success of verticalization after listening to the recording.
Measured: Immediately after a single mental simulation
duration of the first mobilization
Time form the start of the measurement was set at getting out of bed from a sitting position, and the end of the measurement was set at the patient's return to bed.
Measured: Immediately after a single mental simulation
Secondary outcomes (2)
pain level
The average pain she experienced during upright standing. Measured with a 10-point numerical rating scale.
Measured: 3 time points (before and immediately after a single mental simulation, and immediately after verticalization.
anxiety
Measured with a 10-point numerical rating scale.
Measured: upon arrival at the recovery room, before and immediately after a single mental simulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start15 Dec 2017
- Primary completion27 May 2018
- Study completion27 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Prokopowicz, MSc, Wroclaw Medical University
- Investigators
- Anna Prokopowicz, Principal investigator, Department of Applied Obstetrics, Faculty of Health Sciences, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829266
- Sponsor's protocol ID
- 05P/12-2017
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prokopowicz A, Byrka K. Effectiveness of mental simulations on the early mobilization of patients after cesarean section: a randomized controlled trial. Sci Rep. 2021 Nov 22;11(1):22634. doi: 10.1038/s41598-021-02036-1.
PubMed 34811410
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mental Simulations on the Early Mobilization of Patients After Cesarean Section
- ClinicalTrials.gov ID
- NCT04829266
- Acronym / sponsor ID
- 05P/12-2017
- Conditions
- Anxiety, Cesarean Section
- Keywords
- mental simulation, anxiety, verticalization, obstetrics, cesarean section, post-operative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 27 May 2018 (actual)
- Study completion
- 27 May 2018 (actual)
- First posted
- 2 Apr 2021 (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.
Mental simulations can motivate patients for their first verticalization after cesarean section, although perceived anxiety before verticalization may reduce a positive effect of mental simulations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| process simulation group | Experimental | Behavioral: mental simulationan experimental group with process simulation with elements of relaxation |
| outcome simulation group | Experimental | Behavioral: mental simulationan experimental group with outcome simulation with elements of relaxation |
| control group | Other | Behavioral: mental simulationa control group with no process and outcome simulations, but with elements of relaxation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- must be qualified to and undergoing delivery using Cesarean section,
- must be undergoing conduction of anesthesia during Cesarean section,
- must be undergoing the analgesic therapy in the postoperative period,
- must be qualified to mobilization by the medical staff,
- must be fluent in Polish in speaking and writing.
Key exclusion criteria (3 listed)
- any orthopedic dysfunction,
- any neurological dysfunction,
- any psychiatric disease.
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 |
|---|---|---|
| mental simulationAlso: The recording of the process simulation included the order to imagine subsequent elements of the process of mobilization., The recording of the outcome simulation included an optimistic vision of returning to health and fitness., A fragment of the book "Little Prince" by Antoine de Saint-Exupéry, including an order to imagine the elements of the world as seen through the eyes of the main characterAudio recordings with a mental simulation. The women listened to the text using headphones about 10-15 min before verticalization (5 h after arrival in the postoperative room, about 6 h after anesthesia). In each group, the mental training lasted for about 10 min. | Behavioural | control group, outcome simulation group, process simulation group |
Primary outcome
willingness to verticalize
Time frame: Immediately after a single mental simulation
Percentage of women who were willing to verticalize after listening to the recording. Assessed on a on a six-point scale.
verticalization
Time frame: Immediately after a single mental simulation
Percentage of the success of verticalization after listening to the recording.
duration of the first mobilization
Time frame: Immediately after a single mental simulation
Time form the start of the measurement was set at getting out of bed from a sitting position, and the end of the measurement was set at the patient's return to bed.
2 secondary outcomes
pain level
Time frame: 3 time points (before and immediately after a single mental simulation, and immediately after verticalization.
anxiety
Time frame: upon arrival at the recovery room, before and immediately after a single mental simulation.
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 Apr 2021.
- Derived from this study: PubMed 34811410Prokopowicz A, Byrka K. Effectiveness of mental simulations on the early mobilization of patients after cesarean section: a randomized controlled trial. Sci Rep. 2021 Nov 22;11(1):22634. doi: 10.1038/s41598-021-02036-1.
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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.
Anna Prokopowicz principal investigator
Department of Applied Obstetrics, Faculty of Health Sciences, Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mental simulation in people with Anxiety and Cesarean Section, run by Wroclaw Medical University at 1 site in Poland.
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 5 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 Apr 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 Poland. 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?
willingness to verticalize (time frame: Immediately after a single mental simulation). The study lists 3 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 NCT04829266, which also lists 1 linked publication.
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 Apr 2021.