Mental Simulations and Early Mobilization of Patients After Cesarean Section

NCT04829266 | Completed

• 1 other identifier: 05P/12-2017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Cesarean Section

Keywords

mental simulation; anxiety; verticalization; obstetrics; cesarean section; post-operative care

Outcome Measures

Primary Outcomes (3)

• willingness to verticalize

  Percentage of women who were willing to verticalize after listening to the recording. Assessed on a on a six-point scale.

  Immediately after a single mental simulation

• verticalization

  Percentage of the success of verticalization after listening to the recording.

  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.

  Immediately after a single mental simulation

Secondary Outcomes (2)

• pain level

  3 time points (before and immediately after a single mental simulation, and immediately after verticalization.

• anxiety

  upon arrival at the recovery room, before and immediately after a single mental simulation.

Study Arms (3)

process simulation group

EXPERIMENTAL

an experimental group with process simulation with elements of relaxation

Behavioral: mental simulation

outcome simulation group

EXPERIMENTAL

an experimental group with outcome simulation with elements of relaxation

Behavioral: mental simulation

control group

OTHER

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

Behavioral: mental simulation

Interventions

mental simulation 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.

Also known as: 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

control group; outcome simulation group; process simulation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• any orthopedic dysfunction,
• any neurological dysfunction,
• any psychiatric disease.

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

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

Wroclaw, 50-556, Poland

Location

Related Publications (1)

• 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.

  PMID: 34811410 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Anna Prokopowicz

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 2, 2021
• Study Start: December 15, 2017
• Primary Completion: May 27, 2018
• Study Completion: May 27, 2018
• Last Updated: April 2, 2021

Record last verified: 2021-03

Locations

PL (1)