Mental Simulations and Early Mobilization of Patients After Cesarean Section

NCT ID: NCT04829266

Last Updated: 2021-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2018-05-27

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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process simulation group

an experimental group with process simulation with elements of relaxation

Group Type EXPERIMENTAL

mental simulation

Intervention Type BEHAVIORAL

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.

outcome simulation group

an experimental group with outcome simulation with elements of relaxation

Group Type EXPERIMENTAL

mental simulation

Intervention Type BEHAVIORAL

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.

control group

a control group with no process and outcome simulations, but with elements of relaxation

Group Type OTHER

mental simulation

Intervention Type BEHAVIORAL

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.

Interventions

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mental simulation

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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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

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* any orthopedic dysfunction,
* any neurological dysfunction,
* any psychiatric disease.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Anna Prokopowicz, MSc

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Prokopowicz

Role: PRINCIPAL_INVESTIGATOR

Department of Applied Obstetrics, Faculty of Health Sciences, Wroclaw Medical University

Locations

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2nd Chair and Clinic of Gynecology and Obstetrics, Jan Mikulicz-Radecki University Teaching Hospital in Wrocław, Wrocław, Poland

Wroclaw, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 34811410 (View on PubMed)

Other Identifiers

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05P/12-2017

Identifier Type: -

Identifier Source: org_study_id

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