The Effect of Pre-Cesarean Section Guided Imagery

Sponsor

Menekşe Nazlı AKER (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05790954

Collaborator

(none)

Enrollment

Arms

2.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effect of guided imagery applied before cesarean section on preoperative anxiety, fear and physiological parameters.

The study will be carried out in two different groups. The practice will start with meeting the women 3 days before cesarean section. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out random. The following applications will be made to the groups.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Other: Guided imagery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Pre-Cesarean Section Guided Imagery on Preoperative Anxiety, Fear and Physiological Parameters

Anticipated Study Start Date :

Mar 27, 2023

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guided imagery Group	Other: Guided imagery Three days before the cesarean section, the participants will be given a guided imagery audio recording and will be asked to listen to it before going to bed every evening until the day of the cesarean section. On the morning of the cesarean section, after the patient is prepared, the guided imagery audio recording will be played again.
No Intervention: Control Group

Arm

Intervention/Treatment

Experimental: Guided imagery Group

Other: Guided imagery

Three days before the cesarean section, the participants will be given a guided imagery audio recording and will be asked to listen to it before going to bed every evening until the day of the cesarean section. On the morning of the cesarean section, after the patient is prepared, the guided imagery audio recording will be played again.

No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

Change in anxiety [Three days before the cesarean section, immediately before the cesarean]
The State-Trait Anxiety Inventory-S consist of 20 items with four points likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.
Change in Surgical Fear [Three days before the cesarean section, immediately before the cesarean]
Surgical Fear Questionnaire has been developed to determine the level of fear of patients who will undergo electrical surgery for the short and long -term results of surgical operation. The scale is a scales of 11 Likertes, which consist of 8 items, scored between 0-10. Each item 0 is scored as "I'm at all scared", 10 "I'm very scared". The total score of the scale is 0-80. The high score states that surgical fear is high.

Secondary Outcome Measures

systolic and diastolic blood pressure [immediately before the cesarean]
mmHg
heart rate [immediately before the cesarean]
beats per minute
body temperature [immediately before the cesarean]
degrees Celsius
respiratory rate [immediately before the cesarean]
beats per minute
fetal heart rate [immediately before the cesarean]
beats per minute

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

planned cesarean section
Single birth
giving birth at term
No hearing problems
Agreeing to participate in the research and obtaining written permission,

Exclusion Criteria:

Emergency cesarean section due to a health problem of the mother or baby
Not completing the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Menekşe Nazlı AKER

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Menekşe Nazlı AKER, Assist. Prof., Ankara University

ClinicalTrials.gov Identifier:

NCT05790954

Other Study ID Numbers:

15149

First Posted:

Mar 30, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 31, 2023