The Effect of Emotional Support Given During Cesarean Section on Pain, Anxiety, and Surgical Fear

The study was conducted to determine the effect of emotional support given during cesarean section on pain, anxiety and surgical fear.

Study Overview

• Status: Completed
• Conditions: Emotional Support During Cesarean Delivery
• Intervention / Treatment: Behavioral: Emotional support group

Detailed Description

The experimental study sample consisted of 120 women (emotional support group: 60, control group: 60). Data were collected using the Personal Information Form, Visual Analog Scale, State Anxiety Inventory and Surgical Fear Scale. In the comparison between the groups in the study, it was found that there was a statistically significant difference between the mean Visual Analog Scale scores of the women in the experimental and control groups in the pre-test (p<0.05), and no difference in the post-test (p˃0.05). In the post-test measured after emotional support, it was found that there was a statistically significant difference between the State Anxiety Inventory scores, short-term, long-term and total Surgical Fear Scale scores between the groups (p˂0.05). After emotional support, women's pain levels increased, anxiety and surgical fear levels decreased and their satisfaction with emotional support during birth increased. Women who did not receive emotional support had significantly increased pain, anxiety and surgical fear levels.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sivas, Turkey, 58140
    • Sukran Ertekin Pinar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women who had a history of spinal anesthesia for the first time during a cesarean delivery,
• Who were going to have a planned cesarean before spontaneous contractions started,
• Who had no health problems with their babies,
• Who had no physical or mental problems themselves,
• Who had no communication difficulties,
• Women who volunteered to participate were included in the study.

Exclusion Criteria:

• Women who had a normal spontaneous delivery,
• Women who had a cesarean after labor/spontaneous contractions started,
• Women who had any health problems with their babies,
• Women who had a physical or mental illness themselves,
• Women who did not want to participate in the study were not included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Providing emotional support during a caesarean section; Empathetic approach, listening to the feelings and thoughts, welcoming the woman's behavior and expressions, telling her that she is breathing correctly, etc.), not judging the woman, being honest, using a soft and calm tone of voice, taking the baby or asking her opinion, encouraging her to endure the birth process, touching the woman and making physical contact, allowing her to practice her beliefs, showing the baby to the mother as soon as it is born and placing it in her arms.	Behavioral: Emotional support group; Women who met the inclusion criteria and volunteered to participate in the study and were provided emotional support were administered the Personal Information Form, Visual Analog Scale, State Anxiety Inventory and Surgical Fear Scale via face-to-face interview method on the first day of their hospitalization before the caesarean section (pre-test). This application lasted 15-20 minutes. Enter a brief, descriptive title for this arm of the study.
No Intervention: Standard of care Group; The control group did not receive any treatment. Only Visual Analog Scale, State Anxiety Inventory and Surgical Fear Scale were applied (pre-test, post-test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Fear Scale	The Surgical Fear Scale, consisting of eight questions, is an 11-point Likert-type scale and is scored between 0 and 10. It consists of two sub-dimensions measuring short-term fears (items 1-4) and long-term fears (items 5-8) regarding the source of fear. The items in the scale are evaluated as "0: I am not afraid at all" and "10: I am very afraid". Increasing scores indicate increasing fear.	Baseline
State Anxiety Inventory	The inventory consists of four-degree evaluations ranging from "Not at all" to "Completely" in the Likert type. There are 20 items in the inventory, and the individual is required to define how he/she feels at a certain moment and under certain conditions, and to respond by taking into account his/her feelings about the situation he/she is in. High scores indicate high anxiety levels, and low scores indicate low anxiety levels.	Baseline
Visual Analog Scale	The scale is graded as 0-10 cm long, with 0=no pain, 10=the most severe pain. It is applied by the individual marking a point corresponding to the level of pain they feel. The distance between the determined point and the lowest part of the line is evaluated in centimeters. The value found indicates the patient's pain level.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Fear Scale	The Surgical Fear Scale, consisting of eight questions, is an 11-point Likert-type scale and is scored between 0 and 10. It consists of two sub-dimensions measuring short-term fears (items 1-4) and long-term fears (items 5-8) regarding the source of fear. The items in the scale are evaluated as "0: I am not afraid at all" and "10: I am very afraid". Increasing scores indicate increasing fear.	through study completion, an average of 1 year
State Anxiety Inventory	The inventory consists of four-degree evaluations ranging from "Not at all" to "Completely" in the Likert type. There are 20 items in the inventory, and the individual is required to define how he/she feels at a certain moment and under certain conditions, and to respond by taking into account his/her feelings about the situation he/she is in. High scores indicate high anxiety levels, and low scores indicate low anxiety levels.	through study completion, an average of 1 year
Visual Analog Scale	The scale is graded as 0-10 cm long, with 0=no pain, 10=the most severe pain. It is applied by the individual marking a point corresponding to the level of pain they feel. The distance between the determined point and the lowest part of the line is evaluated in centimeters. The value found indicates the patient's pain level.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Cumhuriyet University
• Investigators: Principal Investigator: Sukran Ertekin Pinar, Assoc. Prof. Dr., Cumhuriyet University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Caesarean; Emotional Support; Fear of Surgery
• Other Study ID Numbers: TR SİVAS 06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No