Effects of VE, Focus, Expressive Touch on Pain, Anxiety, Breastfeeding and Mobilization in Women Delivering by Cesarean Section

NCT06740669 | Not Yet Recruiting DMC

• 1 other identifier: 05.11.2024 _ 2024/11 GO 202
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cesarean section is one of the most common surgical interventions in many countries. It is seen that 21.1% of women worldwide, 57.5% in Turkey, give birth by cesarean section. 99.6% of women have pain in the first 24 hours after cesarean section and oral analgesia is not sufficient for pain. It is seen that pain has an effect on recovery and breastfeeding after CS.This study will be conducted to determine the effects of non-pharmacological methods, virtual reality glasses, focusing and expressive touch on pain, anxiety, breastfeeding and mobilization in women giving birth by cesarean section. The ınvestigators aim to contribute to the midwifery and nursing care literature with the findings and results of the study.

Conditions

Women; Postnatal Care

Keywords

Virtual reality,; Focus; Expressive touch; Pain; Anxiety; Breastfeeding

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale

  The numerical pain rating scale (NAS) is used to assess anxiety severity. In the numerical rating scale, anxiety is between 0 and 10 points.

  1 HOUR

• VAS Anxiety

  The numerical pain rating scale (PAS) is used to assess anxiety severity. Anxiety is rated between 0 and 10 points on the numerical rating scale

  1 HOUR

• Mobilization

  The decision to start or continue mobilization will be made by the healthcare professional working in the clinic. The mobilization status of the women will be evaluated. The examiner will note the success or failure of the patient's mobilization along with its duration. (the beginning of the measurement was determined as the moment the patient got up from the sitting position and the end of the measurement was determined as the moment the patient returned to the bed). If the patient got up from the bed and started walking (took at least one step), they received a score of 1 (successful) on the questionnaire form. If they got up but did not take a single step while returning to the sitting position, they received a score of 0. The mobilization time will be measured in minutes

  6HOUR

• 6-Minute Walking Test (6MWT)

  6MWT will be used to evaluate the physical functions of patients. During this test, a 30-meter track with a hard surface will be walked at a normal pace for six minutes. This track is marked every 3 meters and a cone is placed at the end of this 30-meter track and the same track is returned around it. The researcher will record the distance the patient walks in 6 minutes in meters. The test will be performed in a 60-meter long hospital corridor.

  6 HOUR

Secondary Outcomes (1)

• Bristol Breastfeeding Assessment Scale;

  1 HOUR

Study Arms (4)

Control Group

NO INTERVENTION

Women in the control group will receive routine care and breastfeeding support will be provided to these women.

Virtual reality glasses (VR) application

ACTIVE COMPARATOR

Behavioral: Virtual reality glasses (VR) application

Expressive touch applications

ACTIVE COMPARATOR

Behavioral: Those who are applied expressive touch

Focusing

ACTIVE COMPARATOR

Behavioral: Focus

Interventions

Virtual reality glasses (VR) application BEHAVIORAL

It will be evaluated at 1 and 6 hours after the Caesarean section and a relaxing video called Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ, a video containing nature scenes accompanied by nature sounds) will be shown for a maximum of 20 minutes through virtual reality glasses (Toker and Gökduman Keleş, 2024).

Virtual reality glasses (VR) application

Those who are applied expressive touch BEHAVIORAL

Expressive touch does not require any preparation other than warming the hands to the same temperature as the body temperature. During expressive touch practice; the parts of the body that are touched the most are the hands, arms, forehead, hair and shoulders. The hands are massaged during the touch and the arms and shoulders are lightly touched before and after the massage, so that the expressive touch made on the hands is effective (Pinar and Demirel, 2021; Routasalo, 1999) After the evaluation, the researcher will apply expressive touch to one of the mother's hands for an average of 15-20 minutes

Expressive touch applications

Focus BEHAVIORAL

. The researcher mother will be asked to focus on her baby for 10 minutes (Kiliçli Id and Zeyneloglu Id, 2024; Vamour et al., 2019).

Focusing

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Women who do not have any psychiatric illness,
• Those who do not have any vision, hearing or perception problems,
• Those who do not have any communication problems (can speak Turkish),
• Those who accept to participate in the study verbally and in writing were included in the study.
• Those who are between the ages of 18-35,
• Those who have had a singleton birth,
• Those who have had the operation with regional anesthesia (spinal or epidural anesthesia),

You may not qualify if:

• Receiving controlled analgesia after cesarean section
• Having a psychiatric diagnosis such as anxiety and depression
• Those who develop postpartum complications
• Women who want to leave the study at any stage of the study will be excluded from the study

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders; Breast Feeding

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Feeding Behavior; Behavior

Central Study Contacts

MİNE GÖKDUMAN

CONTACT

248 213 82 50; minegokdumankeles@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof. Mine GÖKDUMAN KELEŞ PhD.MİDW,FERY

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 18, 2024
• Study Start: December 20, 2024
• Primary Completion: March 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share