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Clinical Trials/NCT06795828
NCT06795828CompletedNot Applicable

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

Cumhuriyet University1 site in 1 country120 target enrollmentStarted: July 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
Surgical Fear Scale

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 38 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Providing emotional support during a caesarean section

Experimental

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.

Intervention: Emotional support group (Behavioral)

Standard of care Group

No Intervention

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)

Outcomes

Primary Outcomes

Surgical Fear Scale

Time Frame: Baseline

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.

State Anxiety Inventory

Time Frame: Baseline

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.

Visual Analog Scale

Time Frame: Baseline

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.

Secondary Outcomes

  • Surgical Fear Scale(through study completion, an average of 1 year)
  • State Anxiety Inventory(through study completion, an average of 1 year)
  • Visual Analog Scale(through study completion, an average of 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sukran Ertekin Pinar

Assoc. Prof. Dr.

Cumhuriyet University

Study Sites (1)

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