Caesarean SectionRKÇNCT06708585
Information and Progressive Relaxation Exercises
A study testing progressive relaxation exercises and training in people with Caesarean Section and Fear, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of information and progressive relaxation exercises before planned cesarean section on surgical fear, anxiety, postpartum comfort and pain levels.The research will be conducted in experimental design. 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
- Caesarean Section, Fear, Anxiety
- What is being tested?
- progressive relaxation exercises and training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2024to 30 Mar 2025
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-35,
- Primigravida,
- Applied for planned cesarean section,
- Live singleton pregnancy,
- Spinal anesthesia planned,
Who cannot join
- Women who develop postpartum maternal or neonatal complications
- Receiving general anesthesia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ömer Halisdemir University Training and Research Hospital
Niğde
BİRNUR YEŞİLDAĞ, DR, 05336815923, nurumbirnur@gmail.com
İSA GUN, DR, 05530913493, t.isatemur@gmail.com
About this study
Official title: Effects of Planned Pre-Cesarean Information and Progressive Relaxation Exercises on Surgical Fear, Anxiety, Postpartum Comfort and Pain Levels of Primigravida Women: A Randomized Controlled Trial
This study was planned to determine the effect of information and progressive relaxation exercises before planned cesarean section on surgical fear, anxiety, postpartum comfort and pain levels.The research will be conducted in experimental design. The research will begin after receiving written permission from Niğde Ömer Halisdemir University Ethics Committee, Niğde Provincial Health Directorate and Ömer Halisdemir Training and Research Hospital. Pregnant women who are between the ages of 18-35, who are on Primigravida, who apply for a planned cesarean section, who have a live single pregnancy, and who are planned for spinal anesthesia will be included in the study. Before starting the research, the study will begin by obtaining institutional permissions and written permission from the pregnant women. Pre-Assessment Form, Personal Information Form, State Anxiety Scale, Surgical Fear Scale, Postpartum Comfort Scale will be used to collect data. The data will be evaluated on a computer using the IBM SPSS Statistics 24 (Statistical Package for the Social Sciences for Windows) package program. Appropriate statistical analyzes will be used to evaluate the data.
Read the detailed description
There is an increase in the frequency of cesarean sections worldwide (Abdelrahman et al., 2020). WHO states that approximately 18.6 million cesarean sections are performed annually. It is observed that the frequency of cesarean sections in Turkey is increasing every year. According to the Health Statistics Yearbook 2021 data, the rate of cesarean sections in live births is 58.4%, and the rate of primary cesarean sections in live births is 29.1%. These rates show that they are well above the ideal cesarean rate determined by WHO, which should be between 10-15%.
Although there are many known reasons for the increase in cesarean sections, more than 80% of women experience fear and anxiety before and during cesarean sections (Abarghoee et al., 2022; Salmanzadeh et al., 2018). A significant portion of women who undergo cesarean sections experience high levels of anxiety before the procedure (Maleki et al., 2022). Studies show that 63-86% of women who undergo cesarean section have higher levels of fear and anxiety compared to those who undergo general surgery (Ferede et al., 2022). Anxiety related to cesarean section surgery has been associated with physiological and psychological risks. Fear and anxiety experienced before cesarean section can trigger responses from both the sympathetic and parasympathetic nervous systems, as well as affecting hormone levels. As a result, these responses can lead to increased blood pressure and heart rate, and cardiac arrhythmia (Koca et al. 2021). In addition, excessive fear and anxiety before and during surgery can lead to anesthesia complications, increased need for postoperative pain relief, prolonged recovery, delayed initiation of breastfeeding and discharge, higher costs, and decreased satisfaction with the birth experience (Schaal et al. ., 2020 and Hepp et al., 2018). Therefore, it is particularly important to address and reduce fear and anxiety related to cesarean section, as lower levels of fear and anxiety before and during surgery have been associated with greater maternal satisfaction and a more positive overall birth experience (Noben et al., 2019). Managing fear and anxiety can be approached using both pharmaceutical and non-pharmacological methods. Although pharmaceutical approaches are widely used, they can be expensive, sometimes painful, and carry the potential risk of adverse effects on the fetus if they cross the placenta (Eslami et al., 2020). Therefore, there is a focus on using non-pharmacological techniques to alleviate fear and anxiety in women undergoing cesarean section (Abadi et al., 2018). One effective example is the use of relaxation techniques to reduce fear and anxiety (Vagnoli et al., 2019). Frequently used methods include meditation, massage therapy, muscle relaxation exercises, acupuncture, energy healing applications, different breathing techniques such as controlled breathing or diaphragmatic breathing (Mohamady et al. 2022). Relaxation exercise is associated with decreased oxygen consumption levels and decreased activity in the sympathetic nervous system (Ibrahim et al., 2019). One of the known methods of achieving relaxation is progressive relaxation exercise (PGE). Technically, PGE involves the voluntary, systematic tension and complete relaxation of large muscle groups until relaxation is achieved throughout the body. The aim is to ensure that the individual can relax on their own in their daily lives by feeling the difference between tension and relaxation in their body and mind (Burke et al. 2011; Özveren 2011). Considering the high incidence of cesarean section and the prevalence of anxiety and fear as psychological symptoms, it is of great importance to provide comfort and pain support to women. Therefore, the aim of this study was to determine the effects of planned pre-cesarean information and progressive relaxation exercises on surgical fear, anxiety, postpartum comfort and pain levels of primiparous women.
- Conditions
- Caesarean Section, Fear, Anxiety, Pain
- Being tested
- progressive relaxation exercises and training
- Keywords
- Cesarean section, fear, anxiety, comfort, pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exercises and trainingOther
Considering the high incidence of cesarean section and the prevalence of anxiety and fear as psychological symptoms, providing comfort and pain support to women is of great importance. Therefore, the effect of progressive relaxation exercise and education before cesarean section surgery on care outcomes will be determined.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Each pregnant woman who meets the inclusion criteria will be interviewed individually for approximately 15-20 minutes on the day of surgery and data collection forms will be applied. Then, each woman will be given progressive relaxation exercises individually. Exercises will begin two hours before surgery and will be repeated four times. Each exercise will last approximately 20 minutes. Data collection forms will be applied two hours after the completion of the exercise and at the end of surgery. Receives: Other: progressive relaxation exercises and training |
| control group | No intervention | Each pregnant woman in the control group will be administered the individual information form, State Anxiety Scale, and Surgical Fear Scale data collection tools two hours before the surgery and will be released to the routine care of the institution. After two hours, the State Anxiety Scale and Surgical Fear Scale will be administered again. 6 hours after the cesarean section, the woman's pain will be assessed with the VAS pain scale and 24 hours later, the postpartum comfort scale will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Scale
It is understood that as the score obtained from the scale increases, anxiety increases.
Measured: 3 month
Surgical Fear Scale
a high score indicates that surgical fear is high
Measured: 3 month
Secondary outcomes (2)
Visual Analog Scale (VAS)
It consists of a 10 cm long horizontal or vertical line, which is frequently used in the measurement of subjective parameters.
Measured: 3 month
postpartum comfort scale
The lowest score that can be obtained from the scale is 34, while the highest score is 170.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start19 Sep 2024
- Primary completion20 Feb 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caesarean 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a two-group parallel randomized controlled experimental study.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- birnur YEŞİLDAĞ, Dr, Study director, Ömer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708585
- Sponsor's protocol ID
- NIGDE OMER HALISDEMIR UNIVERSI
- Acronym
- RKÇ
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yesildag B, Golbasi Z, Temur I. The effect of information and progressive relaxation exercises before the planned cesarean section on primigravida women's surgical fear, anxiety, pain and postpartum comfort: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Feb 11;26(1):288. doi: 10.1186/s12884-026-08753-7.
PubMed 41668042
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Planned Pre-Cesarean Information and Progressive Relaxation Exercises on Surgical Fear, Anxiety, Postpartum Comfort and Pain Levels of Primigravida Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06708585
- Acronym / sponsor ID
- RKÇ / NIGDE OMER HALISDEMIR UNIVERSI
- Conditions
- Caesarean Section, Fear, Anxiety, Pain
- Keywords
- Cesarean section, fear, anxiety, comfort, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 27 Nov 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.
This study was planned to determine the effect of information and progressive relaxation exercises before planned cesarean section on surgical fear, anxiety, postpartum comfort and pain levels.The research will be conducted in experimental design. The research will begin after receiving written permission from Niğde Ömer Halisdemir University Ethics Committee, Niğde Provincial Health Directorate and Ömer Halisdemir Training and Research Hospital. Pregnant women who are between the ages of 18-35, who are on Primigravida, who apply for a planned cesarean section, who have a live single pregnancy, and who are planned for spinal anesthesia will be included in the study. Before starting the research, the study will begin by obtaining institutional permissions and written permission from the pregnant women. Pre-Assessment Form, Personal Information Form, State Anxiety Scale, Surgical Fear Scale, Postpartum Comfort Scale will be used to collect data. The data will be evaluated on a computer using the IBM SPSS Statistics 24 (Statistical Package for the Social Sciences for Windows) package program. Appropriate statistical analyzes will be used to evaluate the data.
Detailed description
There is an increase in the frequency of cesarean sections worldwide (Abdelrahman et al., 2020). WHO states that approximately 18.6 million cesarean sections are performed annually. It is observed that the frequency of cesarean sections in Turkey is increasing every year. According to the Health Statistics Yearbook 2021 data, the rate of cesarean sections in live births is 58.4%, and the rate of primary cesarean sections in live births is 29.1%. These rates show that they are well above the ideal cesarean rate determined by WHO, which should be between 10-15%.
Although there are many known reasons for the increase in cesarean sections, more than 80% of women experience fear and anxiety before and during cesarean sections (Abarghoee et al., 2022; Salmanzadeh et al., 2018). A significant portion of women who undergo cesarean sections experience high levels of anxiety before the procedure (Maleki et al., 2022). Studies show that 63-86% of women who undergo cesarean section have higher levels of fear and anxiety compared to those who undergo general surgery (Ferede et al., 2022). Anxiety related to cesarean section surgery has been associated with physiological and psychological risks. Fear and anxiety experienced before cesarean section can trigger responses from both the sympathetic and parasympathetic nervous systems, as well as affecting hormone levels. As a result, these responses can lead to increased blood pressure and heart rate, and cardiac arrhythmia (Koca et al. 2021). In addition, excessive fear and anxiety before and during surgery can lead to anesthesia complications, increased need for postoperative pain relief, prolonged recovery, delayed initiation of breastfeeding and discharge, higher costs, and decreased satisfaction with the birth experience (Schaal et al. ., 2020 and Hepp et al., 2018). Therefore, it is particularly important to address and reduce fear and anxiety related to cesarean section, as lower levels of fear and anxiety before and during surgery have been associated with greater maternal satisfaction and a more positive overall birth experience (Noben et al., 2019). Managing fear and anxiety can be approached using both pharmaceutical and non-pharmacological methods. Although pharmaceutical approaches are widely used, they can be expensive, sometimes painful, and carry the potential risk of adverse effects on the fetus if they cross the placenta (Eslami et al., 2020). Therefore, there is a focus on using non-pharmacological techniques to alleviate fear and anxiety in women undergoing cesarean section (Abadi et al., 2018). One effective example is the use of relaxation techniques to reduce fear and anxiety (Vagnoli et al., 2019). Frequently used methods include meditation, massage therapy, muscle relaxation exercises, acupuncture, energy healing applications, different breathing techniques such as controlled breathing or diaphragmatic breathing (Mohamady et al. 2022). Relaxation exercise is associated with decreased oxygen consumption levels and decreased activity in the sympathetic nervous system (Ibrahim et al., 2019). One of the known methods of achieving relaxation is progressive relaxation exercise (PGE). Technically, PGE involves the voluntary, systematic tension and complete relaxation of large muscle groups until relaxation is achieved throughout the body. The aim is to ensure that the individual can relax on their own in their daily lives by feeling the difference between tension and relaxation in their body and mind (Burke et al. 2011; Özveren 2011). Considering the high incidence of cesarean section and the prevalence of anxiety and fear as psychological symptoms, it is of great importance to provide comfort and pain support to women. Therefore, the aim of this study was to determine the effects of planned pre-cesarean information and progressive relaxation exercises on surgical fear, anxiety, postpartum comfort and pain levels of primiparous women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research is a two-group parallel randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: progressive relaxation exercises and trainingEach pregnant woman who meets the inclusion criteria will be interviewed individually for approximately 15-20 minutes on the day of surgery and data collection forms will be applied. Then, each woman will be given progressive relaxation exercises individually. Exercises will begin two hours before surgery and will be repeated four times. Each exercise will last approximately 20 minutes. Data collection forms will be applied two hours after the completion of the exercise and at the end of surgery. |
| control group | No intervention | –Each pregnant woman in the control group will be administered the individual information form, State Anxiety Scale, and Surgical Fear Scale data collection tools two hours before the surgery and will be released to the routine care of the institution. After two hours, the State Anxiety Scale and Surgical Fear Scale will be administered again. 6 hours after the cesarean section, the woman's pain will be assessed with the VAS pain scale and 24 hours later, the postpartum comfort scale will be administered. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 18-35,
- Primigravida,
- Applied for planned cesarean section,
- Live singleton pregnancy,
- Spinal anesthesia planned,
Key exclusion criteria (2 listed)
- Women who develop postpartum maternal or neonatal complications
- Receiving general anesthesia.
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 |
|---|---|---|
| progressive relaxation exercises and trainingConsidering the high incidence of cesarean section and the prevalence of anxiety and fear as psychological symptoms, providing comfort and pain support to women is of great importance. Therefore, the effect of progressive relaxation exercise and education before cesarean section surgery on care outcomes will be determined. | Other | Experimental group |
Primary outcome
State Anxiety Scale
Time frame: 3 month
It is understood that as the score obtained from the scale increases, anxiety increases.
Surgical Fear Scale
Time frame: 3 month
a high score indicates that surgical fear is high
2 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 3 month
postpartum comfort scale
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 41668042Yesildag B, Golbasi Z, Temur I. The effect of information and progressive relaxation exercises before the planned cesarean section on primigravida women's surgical fear, anxiety, pain and postpartum comfort: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Feb 11;26(1):288. doi: 10.1186/s12884-026-08753-7.
- 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. This study is not recruiting at the moment.
birnur YEŞİLDAĞ, Dr study director
Ömer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive relaxation exercises and training in people with Caesarean Section and Fear, run by Nigde Omer Halisdemir University 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BİRNUR YEŞİLDAĞ, Dr (05336815923, nurumbirnur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Scale (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06708585, which also lists 1 linked publication.
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 27 Nov 2024.