Cesarean SectionNCT05511571
Effect of Progressive Relaxation Exercises and TENS on Women Delivering Via Cesarean
A study testing Transcutaneous electrical neural stimulation (TENS), Progressive relaxation exercises (PRE) and Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE) in people with Cesarean Section and Acute Pain, run by Derya Öztürk Özen at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of progressive relaxation exercises and transcutaneous electrical nerve stimulation administered to women delivering via cesarean section on acute pain, breastfeeding behavior, and comfort levels. Single-Blind, Randomized Controlled Study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Acute Pain
- What is being tested?
- Transcutaneous electrical neural stimulation (TENS), Progressive relaxation exercises (PRE) and Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2018to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women who were aged between 18 and 45,
- who were in the postoperative 8th hour,
- who had a transverse cesarean section,
- who, as well as their babies, did not develop any complications during pregnancy, delivery, and the postpartum period.
Who cannot join
- women who did not have an open wound on their body and/or allergic disease on their skin,
- who had cardiac arrhythmia or a pacemaker,
- who had a risk of epilepsy,
- who had epilepsy, eclampsia, kidney or liver disease,
- who had previously applied TENS and PRE methods,
- who were morbidly obese (with a BMI value of over 40),
- who used chronic opioids, antidepressants, and psychoactive drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Relaxation Exercises and Transcutaneous Electrical Nerve Stimulation Administered to Women Delivering Via Cesarean Section on Acute Pain, Breastfeeding Behaviors, and Comfort Levels: A Randomized Controlled Study
This study aimed to determine the effect of progressive relaxation exercises and transcutaneous electrical nerve stimulation administered to women delivering via cesarean section on acute pain, breastfeeding behavior, and comfort levels. Single-Blind, Randomized Controlled Study. This study was carried out in the obstetrics and gynecology clinic of a university hospital affiliated with the Ministry of Health in Turkey between August 20, 2018 and April 15, 2019. A total of 120 participants were randomly assigned to one of four groups, which included a transcutaneous electrical neural stimulation (TENS) group, a progressive relaxation exercises (PRE) group, a combined intervention (TENS+PRE) group, and a control group. Data were collected with a data collection form, the visual analogue scale (VAS), the LATCH breastfeeding diagnostic tool (LATCH), and the postpartum comfort scale (PCS). In the analysis of the data, numbers, percentages, and chi-square tests were used. Also, median values, Wilcoxon Signed-rank test, and Kruskal-Wallis H test were employed for continuous variables.
- Conditions
- Cesarean Section, Acute Pain
- Being tested
- Transcutaneous electrical neural stimulation (TENS), Progressive relaxation exercises (PRE), Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)
- Keywords
- cesarean section, pain, breastfeeding, comfort, muscle relaxation, transcutaneous electrical neural stimulation
- Medical subject headings
- Acute Pain, Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical neural stimulation (TENS)Device
The TENS group: TENS application was implemented by the researchers in the patient room. The conventional TENS application took 30 minutes per session. The application continued until frequency reached 100 Hz, the pulse width reached 100 μs, and the current impedance reached a point where the women felt needling or tingling according to their tolerance. Before the application, the women were asked to lie in a supine position, and the area/skin where TENS would be applied was cleaned and dried. Two electrodes of TENS were placed 2 cm above the cesarean incision, and the other two electrodes 2 cm below the incision. The women were allowed to rest during the application, and they were accompanied by the researcher. A total of five TENS sessions, including two at four-hour intervals on the first day and three at eight-hour intervals on the second day, were held.
Progressive relaxation exercises (PRE)Other
The PRE group: The PRE application was implemented in the patient room. A quiet and calm environment was prepared in the room for the intervention. The PRE application was implemented by the women under the researchers' instructions. Each session lasted 30 minutes. A total of five sessions, including two at four-hour intervals on the first day and three at eight-hour intervals on the second day, were held. The PRE application includes exercises based on stretching and then the relaxation of different muscle groups, accompanied by deep breathing. The exercises were carried out in the following way: First doing a deep breathing exercise and then stretching all the muscles from feet to face accompanied by breathing in, keeping the breath, and finally relaxing the muscles by breathing out at the same time.
Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)Other
The TENS+PRE group: The PRE and TENS applications were carried out together in this group. The administration of the interventions was the same as in groups where only TENS and only PRE applications were carried out. In this group, first, a 30-minute PRE application was implemented, which was followed by a 30-minute-TENS application.
| Study group | Role | What they receive |
|---|---|---|
| TENS group | Experimental | Transcutaneous electrical neural stimulation (TENS) Receives: Device: Transcutaneous electrical neural stimulation (TENS) |
| PRE group | Experimental | Progressive relaxation exercises (PRE) Receives: Other: Progressive relaxation exercises (PRE) |
| TENS+PRE group | Experimental | Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE) Receives: Other: Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE) |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute pain
The Visual Analog Scale (VAS) was used in the evaluation of acute pain.
Measured: VAS was applied in the first eighth hour during the postoperative 48 hours, before and after each application in the intervention groups, and in the control group at the times corresponding to the applications in the intervention groups.
Secondary outcomes (2)
Change in breastfeeding behavior
The LATCH Breastfeeding Diagnostic Tool (LATCH) was used in the evaluation of breastfeeding behavior.
Measured: LATCH was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.
Change in comfort level
The Postpartum Comfort Scale was used in the evaluation of comfort level.
Measured: Postpartum Comfort Scale was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start20 Aug 2018
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derya Öztürk Özen
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University, Saglik Bilimleri Universitesi
- Responsible party
- Sponsor-investigator, Derya Öztürk Özen, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511571
- Sponsor's protocol ID
- KA-17142
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises and Transcutaneous Electrical Nerve Stimulation Administered to Women Delivering Via Cesarean Section on Acute Pain, Breastfeeding Behaviors, and Comfort Levels: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05511571
- Acronym / sponsor ID
- KA-17142
- Conditions
- Cesarean Section, Acute Pain
- Keywords
- cesarean section, pain, breastfeeding, comfort, muscle relaxation, transcutaneous electrical neural stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Derya Öztürk ÖzenUniversity, hospital or other
- Collaborators
- Hacettepe University, Saglik Bilimleri Universitesi
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 23 Aug 2022 (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.
This study aimed to determine the effect of progressive relaxation exercises and transcutaneous electrical nerve stimulation administered to women delivering via cesarean section on acute pain, breastfeeding behavior, and comfort levels. Single-Blind, Randomized Controlled Study. This study was carried out in the obstetrics and gynecology clinic of a university hospital affiliated with the Ministry of Health in Turkey between August 20, 2018 and April 15, 2019. A total of 120 participants were randomly assigned to one of four groups, which included a transcutaneous electrical neural stimulation (TENS) group, a progressive relaxation exercises (PRE) group, a combined intervention (TENS+PRE) group, and a control group. Data were collected with a data collection form, the visual analogue scale (VAS), the LATCH breastfeeding diagnostic tool (LATCH), and the postpartum comfort scale (PCS). In the analysis of the data, numbers, percentages, and chi-square tests were used. Also, median values, Wilcoxon Signed-rank test, and Kruskal-Wallis H test were employed for continuous variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TENS group | Experimental | Device: Transcutaneous electrical neural stimulation (TENS)Transcutaneous electrical neural stimulation (TENS) |
| PRE group | Experimental | Other: Progressive relaxation exercises (PRE)Progressive relaxation exercises (PRE) |
| TENS+PRE group | Experimental | Other: Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE) |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women who were aged between 18 and 45,
- who were in the postoperative 8th hour,
- who had a transverse cesarean section,
- who, as well as their babies, did not develop any complications during pregnancy, delivery, and the postpartum period.
Key exclusion criteria (7 listed)
- women who did not have an open wound on their body and/or allergic disease on their skin,
- who had cardiac arrhythmia or a pacemaker,
- who had a risk of epilepsy,
- who had epilepsy, eclampsia, kidney or liver disease,
- who had previously applied TENS and PRE methods,
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 |
|---|---|---|
| Transcutaneous electrical neural stimulation (TENS)The TENS group: TENS application was implemented by the researchers in the patient room. The conventional TENS application took 30 minutes per session. The application continued until frequency reached 100 Hz, the pulse width reached 100 μs, and the current impedance reached a point where the women felt needling or tingling according to their tolerance. Before the application, the women were asked to lie in a supine position, and the area/skin where TENS would be applied was cleaned and dried. Two electrodes of TENS were placed 2 cm above the cesarean incision, and the other two electrodes 2 cm below the incision. The women were allowed to rest during the application, and they were accompanied by the researcher. A total of five TENS sessions, including two at four-hour intervals on the first day and three at eight-hour intervals on the second day, were held. | Device | TENS group |
| Progressive relaxation exercises (PRE)The PRE group: The PRE application was implemented in the patient room. A quiet and calm environment was prepared in the room for the intervention. The PRE application was implemented by the women under the researchers' instructions. Each session lasted 30 minutes. A total of five sessions, including two at four-hour intervals on the first day and three at eight-hour intervals on the second day, were held. The PRE application includes exercises based on stretching and then the relaxation of different muscle groups, accompanied by deep breathing. The exercises were carried out in the following way: First doing a deep breathing exercise and then stretching all the muscles from feet to face accompanied by breathing in, keeping the breath, and finally relaxing the muscles by breathing out at the same time. | Other | PRE group |
| Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE)The TENS+PRE group: The PRE and TENS applications were carried out together in this group. The administration of the interventions was the same as in groups where only TENS and only PRE applications were carried out. In this group, first, a 30-minute PRE application was implemented, which was followed by a 30-minute-TENS application. | Other | TENS+PRE group |
Primary outcome
Change in acute pain
Time frame: VAS was applied in the first eighth hour during the postoperative 48 hours, before and after each application in the intervention groups, and in the control group at the times corresponding to the applications in the intervention groups.
The Visual Analog Scale (VAS) was used in the evaluation of acute pain.
2 secondary outcomes
Change in breastfeeding behavior
Time frame: LATCH was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.
Change in comfort level
Time frame: Postpartum Comfort Scale was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical neural stimulation (TENS), Progressive relaxation exercises (PRE) and Transcutaneous electrical neural stimulation (TENS) and Progressive relaxation exercises (PRE) in people with Cesarean Section and Acute Pain, run by Derya Öztürk Özen at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in acute pain (time frame: VAS was applied in the first eighth hour during the postoperative 48 hours, before and after each application in the intervention groups, and in the control group at the times corresponding to the applications in the intervention groups.). 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 23 Aug 2022.