CClinicalTrials.gg
Not yet recruitingNCT06740669Updated Dec 18, 2024

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

An interventional study of Virtual reality glasses (VR) application and Those who are applied expressive touch in Women and Postnatal Care, sponsored by Burdur Mehmet Akif Ersoy University. Not yet recruiting. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Burdur Mehmet Akif Ersoy University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
208
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Women
  • Postnatal Care

Keywords

  • Virtual reality,
  • Focus
  • Expressive touch
  • Pain
  • Anxiety
  • Breastfeeding
03

In context

Lead sponsor

Burdur Mehmet Akif Ersoy University is the lead sponsor of 48 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
208 participants (estimated)

Study arms

  • No intervention
    Control Group

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

  • Active comparator
    Virtual reality glasses (VR) application

    Behavioral: Virtual reality glasses (VR) application

  • Active comparator
    Expressive touch applications

    Behavioral: Those who are applied expressive touch

  • Active comparator
    Focusing

    Behavioral: Focus

Interventions

  • BehavioralVirtual 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).

  • BehavioralThose 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 evaluation, the researcher will apply expressive touch to one of the mother's hands for an average of 15-20 minutes

  • BehavioralFocus

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 HOUR

  2. 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

    Time frame: 1 HOUR

  3. 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

    Time frame: 6HOUR

  4. 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.

    Time frame: 6 HOUR

Secondary outcomes

  1. Bristol Breastfeeding Assessment Scale;

    "Bristol Breastfeeding Assessment Scale (BEDÖ) was developed by Jenny Ingram in 2014 and adapted to Turkish by Dolgun and her friends in 2017 . The scale was developed to evaluate breastfeeding problems and adequacy encountered frequently in the postpartum period. The mother is observed by a health professional during breastfeeding and the form is filled out by evaluating the mother and the baby in line with the criteria. The application time of the scale is 5-10 minutes. While the Cronbach's Alpha value of the original form of the tool was found to be 0.68, it was found to be 0.77 in the Turkish adaptation study. The measurement tool is a Likert-type scale consisting of 4 items: "positioning", "holding", "sucking" and "swallowing". Positioning/Holding: The baby should be well supported, leaned against the mother's body, laid on its side and its neck should not be bent. The nose should be opposite the nipple, the mother sho

    Time frame: 1 HOUR

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06740669
Lead sponsor
Burdur Mehmet Akif Ersoy University
Responsible party
Mine Gokduman Keles (Asst.Prof. Mine GÖKDUMAN KELEŞ PhD.MİDW,FERY, Burdur Mehmet Akif Ersoy University) — Principal investigator
First posted
Dec 18, 2024
Start date
Dec 20, 2024 (estimated)
Primary completion
Mar 30, 2025 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Dec 18, 2024

Study contacts

MİNE GÖKDUMAN
Contact
minegokdumankeles@gmail.com
248 213 82 50

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion