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Completed

NCT Number: NCT06795828

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.

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Key information

Conditions

Emotional Support During Cesarean Delivery Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sukran Ertekin Pinar

Sivas, 58140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emotional support group

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Surgical Fear Scale

    Time frame: through study completion, an average of 1 year

    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.

  2. State Anxiety Inventory

    Time frame: through study completion, an average of 1 year

    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.

  3. Visual Analog Scale

    Time frame: through study completion, an average of 1 year

    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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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