WomenNCT06740669
Effects of VE, Focus, Expressive Touch on Pain, Anxiety, Breastfeeding and Mobilization in Women Delivering by Cesarean Section
A study testing Virtual reality glasses (VR) application, Those who are applied expressive touch and Focus in people with Women and Postnatal Care, run by Burdur Mehmet Akif Ersoy University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women, Postnatal Care
- What is being tested?
- Virtual reality glasses (VR) application, Those who are applied expressive touch and Focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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),
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Women, Postnatal Care
- Being tested
- Virtual reality glasses (VR) application, Those who are applied expressive touch, Focus
- Keywords
- Virtual reality,, Focus, Expressive touch, Pain, Anxiety, Breastfeeding
- Medical subject headings
- Pain, Anxiety Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glasses (VR) applicationBehavioural
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).
Those who are applied expressive touchBehavioural
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
FocusBehavioural
. The researcher mother will be asked to focus on her baby for 10 minutes (Kiliçli Id and Zeyneloglu Id, 2024; Vamour et al., 2019).
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described Receives: Behavioral: Virtual reality glasses (VR) application |
| Expressive touch applications | Active comparator | Not described Receives: Behavioral: Those who are applied expressive touch |
| Focusing | Active comparator | Not described Receives: Behavioral: Focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 1 HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Gokduman Keles, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740669
- Sponsor's protocol ID
- 05.11.2024 _ 2024/11 GO 202
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of VE, Focus, Expressive Touch on Pain, Anxiety, Breastfeeding and Mobilization in Women Delivering by Cesarean Section
- ClinicalTrials.gov ID
- NCT06740669
- Acronym / sponsor ID
- 05.11.2024 _ 2024/11 GO 202
- Conditions
- Women, Postnatal Care
- Keywords
- Virtual reality,, Focus, Expressive touch, Pain, Anxiety, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality glasses (VR) applicationIt 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). | Behavioural | Virtual reality glasses (VR) application |
| Those who are applied expressive touchExpressive 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 | Behavioural | Expressive touch applications |
| 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). | Behavioural | Focusing |
Primary outcome
Visual Analog Scale
Time frame: 1 HOUR
The numerical pain rating scale (NAS) is used to assess anxiety severity. In the numerical rating scale, anxiety is between 0 and 10 points.
VAS Anxiety
Time frame: 1 HOUR
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
Mobilization
Time frame: 6HOUR
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
6-Minute Walking Test (6MWT)
Time frame: 6 HOUR
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.
1 secondary outcome
Bristol Breastfeeding Assessment Scale;
Time frame: 1 HOUR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality glasses (VR) application, Those who are applied expressive touch and Focus in people with Women and Postnatal Care, run by Burdur Mehmet Akif Ersoy University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MİNE GÖKDUMAN (248 213 82 50, minegokdumankeles@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 1 HOUR). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.