Mental Simulations and Early Mobilization of Patients After Cesarean Section

Anxiety Clinical Trial

Official title:

Effect of Mental Simulations on the Early Mobilization of Patients After Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829266
• Other study ID #: 05P/12-2017
• Status: Completed
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: May 27, 2018

Study information

• Verified date: March 2021
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 27, 2018
• Est. primary completion date: May 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Cesarean Section

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Poland	2nd Chair and Clinic of Gynecology and Obstetrics, Jan Mikulicz-Radecki University Teaching Hospital in Wroclaw, Wroclaw, Poland	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	verticalization	Percentage of the success of verticalization after listening to the recording.	Immediately after a single mental simulation
Primary	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	pain level	The average pain she experienced during upright standing. Measured with a 10-point numerical rating scale.	3 time points (before and immediately after a single mental simulation, and immediately after verticalization.
Secondary	anxiety	Measured with a 10-point numerical rating scale.	upon arrival at the recovery room, before and immediately after a single mental simulation.