The Effect of Pre-Cesarean Section Guided Imagery

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05790954
• Other study ID #: 15149
• Status: Completed
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2024
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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.

Locations

Country	Name	City	State
Turkey	Neslihan Yilmaz Sezer	Ankara	Mamak

Sponsors (1)

Lead Sponsor	Collaborator
Menekse Nazli AKER

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety	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.	Three days before the cesarean section, Fifteen minutes after preparation for cesarean section
Primary	Change in Surgical Fear	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.	Three days before the cesarean section, Fifteen minutes after preparation for cesarean section
Secondary	systolic and diastolic blood pressure	mmHg	Fifteen minutes after preparation for cesarean section
Secondary	heart rate	beats per minute	Fifteen minutes after preparation for cesarean section
Secondary	body temperature	degrees Celsius	Fifteen minutes after preparation for cesarean section
Secondary	respiratory rate	beats per minute	Fifteen minutes after preparation for cesarean section
Secondary	fetal heart rate	beats per minute	Fifteen minutes after preparation for cesarean section