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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

BİRNUR YEŞİLDAĞ, Dr contact

05336815923

nurumbirnur@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ömer Halisdemir University Training and Research Hospital

    Niğde

    BİRNUR YEŞİLDAĞ, DR, 05336815923, nurumbirnur@gmail.com

    İSA GUN, DR, 05530913493, t.isatemur@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06708585
Study groupRoleWhat they receive
Experimental groupExperimentalEach 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 groupNo interventionEach 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.

  1. State Anxiety Scale

    It is understood that as the score obtained from the scale increases, anxiety increases.

    Measured: 3 month

  2. Surgical Fear Scale

    a high score indicates that surgical fear is high

    Measured: 3 month

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted27 Nov 2024
  2. Study start19 Sep 2024
  3. Primary completion20 Feb 2025 (estimated)
  4. Study completion30 Mar 2025 (estimated)

Resources

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)
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

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.

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