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Not yet recruiting NCT06740669

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

No phase Interventional Women Postnatal Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality glasses (VR) application, Those who are applied expressive touch, Focus.
Who it may be relevant to
Registry conditions: Women, Postnatal Care. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

Subject: Cesarean section is one of the most common surgical interventions in many countries. It is observed that 21.1% of women worldwide and 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 . Pain is observed to have an effect on recovery and breastfeeding after CS . In the literature, it has been reported that some applications such as acupressure, acupuncture, relaxation exercises, foot reflexology, aromatherapy, music, transcutaneous electrical nerve stimulation, and distraction, which are non-pharmacological methods in the adjunctive treatment of postoperative pain, reduce pain, fatigue, and anxiety, accelerate mobilization, and positively affect breastfeeding .. In general, non-pharmacological methods significantly affect pain after cesarean section . Based on these studies, it is seen that non-pharmacological methods applied to reduce anxiety and pain after cesarean section are effective. In recent years, virtual reality glasses (VR) , focusing and expressive touching have taken their place in the literature. When the literature is examined, it is seen that virtual reality glasses, focus and expressive touch reduce the pain level and provide anxiety reduction.

No study has been found on the application of virtual reality glasses, focus and expressive touch in reducing pain and anxiety after cesarean section. This study will be conducted to determine the effects of virtual reality glasses, focus and expressive touch, which are non-pharmacological methods, on pain, anxiety, breastfeeding and mobilization in women who give birth by cesarean section.

The ınvestigators aim for the findings and results of the study to contribute to the midwifery and nursing care literature.

Interventions

  • Behavioral Virtual reality glasses (VR) application
    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).
  • Behavioral Those who are applied expressive touch
    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 evaluatio
  • Behavioral Focus
    . The researcher mother will be asked to focus on her baby for 10 minutes (Kiliçli Id and Zeyneloglu Id, 2024; Vamour et al., 2019).

Primary outcome measures

  • Visual Analog Scale [Time frame: 1 HOUR]
  • VAS Anxiety [Time frame: 1 HOUR]
  • Mobilization [Time frame: 6HOUR]
  • 6-Minute Walking Test (6MWT) [Time frame: 6 HOUR]
Secondary outcome measures (1)
  • Bristol Breastfeeding Assessment Scale; [Time frame: 1 HOUR]

Eligibility criteria

Inclusion criteria

\- 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),

Exclusion criteria

  • Exclusion Criteria from the Study
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06740669 · 05.11.2024 _ 2024/11 GO 202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗