Cesarean SectionNCT07880587
Reflexology Hand Massage After Cesarean Section
A study testing Reflexology Hand Massage and Stroking Hand Massage in people with Cesarean Section and Anxiety, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Background: Globally, cesarean section (CS) rates are rapidly increasing. Although cesarean delivery is a life-saving surgical intervention, it can lead to adverse outcomes such as anxiety, decreased maternal satisfaction, and alterations in hemodynamic parameters. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Anxiety, Postoperative Period
- What is being tested?
- Reflexology Hand Massage and Stroking Hand Massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2026to 30 Jan 2027
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 20 and 35 years.
- Underwent an elective term cesarean delivery.
- Having a healthy newborn with a 1-minute Apgar score > 7.
- Being at the 4th postoperative hour.
- No diagnosed psychological disorders (such as depression or anxiety disorder).
- Not using any anxiolytic medications.
- Having no contraindications for hand massage (i.e., absence of skin lesions, burns, or musculoskeletal pathologies on the hands).
Who cannot join
- Development of severe postoperative complications (e.g., excessive bleeding, infection).
- Conditions requiring admission to the Intensive Care Unit (ICU).
- Presence of postnatal complications.
- Having chronic or ongoing systemic diseases.
- Having any skin lesions, burns, open wounds, or musculoskeletal pathologies on the hands.
- Inability to speak and understand Turkish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University Research and Application Hospital
Izmir, 35340
Buse Güler, PhD, +90 232 412 69 70, busebahitli@gmail.com
About this study
Official title: The Effect of Reflexology Hand Massage on Anxiety, Satisfaction, and Hemodynamic Parameters in the Early Postoperative Period After Cesarean Section: A Randomized Controlled Trial
Background: Globally, cesarean section (CS) rates are rapidly increasing. Although cesarean delivery is a life-saving surgical intervention, it can lead to adverse outcomes such as anxiety, decreased maternal satisfaction, and alterations in hemodynamic parameters. Hand massage, as a complementary nursing intervention, is considered an effective method for alleviating these issues by promoting physiological and psychological well-being.
Objective: The aim of this study is to examine the effects of reflexology hand massage and stroking hand massage on anxiety, satisfaction, and hemodynamic parameters in women during the early postoperative period following a cesarean section.
Methods: This study is designed as a single-blind, randomized, placebo-controlled trial. The study population will consist of women who undergo cesarean delivery and are hospitalized in the Obstetrics and Gynecology Ward of Dokuz Eylul University Research and Application Hospital. The study sample will include women aged 20-35 years who undergo a term, elective cesarean delivery between April 2026 and January 2027, and are at their 4th postoperative hour. The experimental group will receive a 20-minute reflexology hand massage, while the control group will receive a 20-minute stroking hand massage (placebo). Due to the single-blind nature of the study, participants will only be informed that they will receive a "hand massage," without specifying the exact technique (reflexology or stroking). Satisfaction will be measured using a Visual Analog Scale (VAS), and anxiety will be measured using the State Anxiety Inventory (STAI) before the intervention and 30 minutes after the massage application. Data obtained from the study will be analyzed using the SPSS (IBM SPSS Statistics, Version 25) software. Descriptive statistics will be presented as mean, standard deviation, and median (minimum-maximum) for continuous variables, and as frequencies and percentages for categorical variables. The conformity of the data to normal distribution will be evaluated using the Kolmogorov-Smirnov and Shapiro-Wilk tests. For the comparison of continuous variables between groups, the Independent Samples t-test will be used for normally distributed data, and the Mann-Whitney U test for non-normally distributed data. For within-group comparisons of time-dependent measurements, Repeated Measures ANOVA will be applied if the normality assumption is met, whereas the Friedman test will be used if it is not met. To compare time-dependent changes between groups, a two-way repeated measures ANOVA will be utilized for normally distributed data, and Generalized Linear Models or appropriate non-parametric methods will be employed for non-normally distributed data. Categorical variables will be compared using the Chi-square test or Fisher's Exact test when necessary. The statistical significance level will be set at p < 0.05 for all analyses.
Read the detailed description
Cesarean section (CS) rates are rapidly increasing worldwide. Although cesarean delivery is a life-saving surgical procedure, the anxiety it causes can lead to negative consequences such as decreased maternal satisfaction and changes in hemodynamic parameters. Manual massage, which is among the complementary nursing interventions, is considered an effective method in reducing these problems by supporting physiological and psychological well-being.
- Conditions
- Cesarean Section, Anxiety, Postoperative Period
- Being tested
- Reflexology Hand Massage, Stroking Hand Massage
- Keywords
- Massage, cesarean delivery, anxiety, patient satisfaction, hemodynamic parameters
- Medical subject headings
- Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflexology Hand MassageOther
A 20-minute reflexology hand massage administered by the researcher at the 4th postoperative hour following an elective cesarean delivery. This intervention involves applying targeted manual pressure to specific reflexology points on both hands to promote relaxation, reduce postoperative state anxiety, and support hemodynamic stability.
Stroking Hand MassageOther
A 20-minute simple stroking hand massage administered by the researcher at the 4th postoperative hour following an elective cesarean delivery. This placebo intervention involves gentle, superficial strokes on the hands without exerting any pressure on specific reflex points. It is designed solely to control for the time and physical attention provided to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology Hand Massage | Experimental | A 20-minute reflexology hand massage applied by the researcher. Pressure is applied to specific reflex points on the hands to promote relaxation, reduce anxiety, and support hemodynamic stability. Receives: Other: Reflexology Hand Massage |
| Stroking Hand Massage | Placebo comparator | Participants in this group will receive a 20-minute stroking hand massage as a placebo intervention, applied at the 4th postoperative hour after elective cesarean delivery. Receives: Other: Stroking Hand Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Levels
Anxiety will be assessed using the State Anxiety Inventory (STAI). The state subscale consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80. Higher scores indicate higher levels of state anxiety.
Measured: Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Secondary outcomes (5)
Change in Patient Satisfaction
Patient satisfaction will be evaluated using a Visual Analog Scale (VAS). The scale is a 10-centimeter line ranging from 0 to 10, where 0 represents 'completely dissatisfied' and 10 represents 'completely satisfied.' Higher scores indicate greater satisfaction with the postoperative care.
Measured: Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Change in Hemodynamic Parameters1
Physiological evaluation will include the measurement of systolic blood pressure (mmHg), diastolic blood pressure (mmHg)
Measured: 1 Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Change in Hemodynamic Parameters 2
Physiological evaluation will include the measurement of heart rate (beats per minute)
Measured: 2 Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Change in Hemodynamic Parameters 3
Physiological evaluation will include the measurement of respiratory rate (breaths per minute)
Measured: 3 Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Change in Hemodynamic Parameters 4
Physiological evaluation will include the measurement of peripheral oxygen saturation (SpO2, %).
Measured: 4 Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start26 Jun 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Güler, Dokuz Eylul University
- Investigators
- Gizem Göktuna, Study director, Dokuz Eylul UniversityErkan Çağlıyan, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880587
- Sponsor's protocol ID
- 2026/18-06
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Abidi, S. M. A., Abbas, S., Abidi, S. T. F., Hussain, N., & Haresh, S. (2023). Application of the Robson classification in assessing cesarean section rates: An audit of a tertiary care hospital's gynecology department in Karachi, Pakistan. medRxiv. https://doi.org/10.1101/2023.04.30.23289336 2. World Health Organization. (2021). Caesarean section rates continue to rise, amid growing inequalities in access. https://www.who.int/news/item/16-06-2021-caesarean-section-rates-continue-to-rise-amid-growing-inequalities-in-access 3. Yang, J. (2025). Cesarean sections in selected countries 2022. Statista. 4. Uğuryol, M., & Dönmez, A. (2022). The effect of reflexology treatment on anxiety. Journal of Psychiatric Nursing, 13(1), 24-30. https://doi.org/10.14744/phd.2021.05579 5. Roshangar, F., Lotfi, M., Aghazadeh, A. M., Asghari, E., & Aghaei, E. (2020). The effect of "nurse companionship" on anxiety and vital sign changes of cesarean section candidates: A randomized control trial. Crescent Journal of Medical and Biological Sciences, 7(2), 267-273. 6. Kunikata H, Watanabe K, Miyoshi M, Tanioka T. The effects measurement of hand massage by the 7. autonomic activity and psychological indicators. Journal of Medical Investigation. 2012;59[1-2]:206-12 8. Aksu, S., & Karaca, P. P. (2021). The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study. Complementary Medicine Research, 28(4), 336-343. 9. Joseph, A., Frank, R. W., & Ramyashree, S. (2024). Postoperative Pain Reduction in "Cesarean Mothers" with Hand and Foot Massage. Journal of Health and Allied Sciences NU, 14(Suppl S1), S18-S20. 10. Kiliçli, A., & Zeyneloglu, S. (2024). Effect of Reflexology on Pain, Fatigue, Sleep Quality, and Lactation in Postpartum Primiparous Women After Cesarean Delivery: A Randomized Controlled Trial. Journal of Human Lactation, 40(2), 221-236. 11. Mahima, A., Saraswathy, K., Venkatesan, L., Vijayalakshmi, K., & Dhanalakshmi, V. (2025). Effective
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reflexology Hand Massage on Anxiety, Satisfaction, and Hemodynamic Parameters in the Early Postoperative Period After Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07880587
- Acronym / sponsor ID
- 2026/18-06
- Conditions
- Cesarean Section, Anxiety, Postoperative Period
- Keywords
- Massage, cesarean delivery, anxiety, patient satisfaction, hemodynamic parameters
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 19 Oct 2026 (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.
Background: Globally, cesarean section (CS) rates are rapidly increasing. Although cesarean delivery is a life-saving surgical intervention, it can lead to adverse outcomes such as anxiety, decreased maternal satisfaction, and alterations in hemodynamic parameters. Hand massage, as a complementary nursing intervention, is considered an effective method for alleviating these issues by promoting physiological and psychological well-being.
Objective: The aim of this study is to examine the effects of reflexology hand massage and stroking hand massage on anxiety, satisfaction, and hemodynamic parameters in women during the early postoperative period following a cesarean section.
Methods: This study is designed as a single-blind, randomized, placebo-controlled trial. The study population will consist of women who undergo cesarean delivery and are hospitalized in the Obstetrics and Gynecology Ward of Dokuz Eylul University Research and Application Hospital. The study sample will include women aged 20-35 years who undergo a term, elective cesarean delivery between April 2026 and January 2027, and are at their 4th postoperative hour. The experimental group will receive a 20-minute reflexology hand massage, while the control group will receive a 20-minute stroking hand massage (placebo). Due to the single-blind nature of the study, participants will only be informed that they will receive a "hand massage," without specifying the exact technique (reflexology or stroking). Satisfaction will be measured using a Visual Analog Scale (VAS), and anxiety will be measured using the State Anxiety Inventory (STAI) before the intervention and 30 minutes after the massage application. Data obtained from the study will be analyzed using the SPSS (IBM SPSS Statistics, Version 25) software. Descriptive statistics will be presented as mean, standard deviation, and median (minimum-maximum) for continuous variables, and as frequencies and percentages for categorical variables. The conformity of the data to normal distribution will be evaluated using the Kolmogorov-Smirnov and Shapiro-Wilk tests. For the comparison of continuous variables between groups, the Independent Samples t-test will be used for normally distributed data, and the Mann-Whitney U test for non-normally distributed data. For within-group comparisons of time-dependent measurements, Repeated Measures ANOVA will be applied if the normality assumption is met, whereas the Friedman test will be used if it is not met. To compare time-dependent changes between groups, a two-way repeated measures ANOVA will be utilized for normally distributed data, and Generalized Linear Models or appropriate non-parametric methods will be employed for non-normally distributed data. Categorical variables will be compared using the Chi-square test or Fisher's Exact test when necessary. The statistical significance level will be set at p < 0.05 for all analyses.
Detailed description
Cesarean section (CS) rates are rapidly increasing worldwide. Although cesarean delivery is a life-saving surgical procedure, the anxiety it causes can lead to negative consequences such as decreased maternal satisfaction and changes in hemodynamic parameters. Manual massage, which is among the complementary nursing interventions, is considered an effective method in reducing these problems by supporting physiological and psychological well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reflexology Hand Massage | Experimental | Other: Reflexology Hand MassageA 20-minute reflexology hand massage applied by the researcher. Pressure is applied to specific reflex points on the hands to promote relaxation, reduce anxiety, and support hemodynamic stability. |
| Stroking Hand Massage | Placebo comparator | Other: Stroking Hand MassageParticipants in this group will receive a 20-minute stroking hand massage as a placebo intervention, applied at the 4th postoperative hour after elective cesarean delivery. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women aged between 20 and 35 years.
- Underwent an elective term cesarean delivery.
- Having a healthy newborn with a 1-minute Apgar score > 7.
- Being at the 4th postoperative hour.
- No diagnosed psychological disorders (such as depression or anxiety disorder).
Key exclusion criteria (6 listed)
- Development of severe postoperative complications (e.g., excessive bleeding, infection).
- Conditions requiring admission to the Intensive Care Unit (ICU).
- Presence of postnatal complications.
- Having chronic or ongoing systemic diseases.
- Having any skin lesions, burns, open wounds, or musculoskeletal pathologies on the hands.
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 |
|---|---|---|
| Reflexology Hand MassageA 20-minute reflexology hand massage administered by the researcher at the 4th postoperative hour following an elective cesarean delivery. This intervention involves applying targeted manual pressure to specific reflexology points on both hands to promote relaxation, reduce postoperative state anxiety, and support hemodynamic stability. | Other | Reflexology Hand Massage |
| Stroking Hand MassageA 20-minute simple stroking hand massage administered by the researcher at the 4th postoperative hour following an elective cesarean delivery. This placebo intervention involves gentle, superficial strokes on the hands without exerting any pressure on specific reflex points. It is designed solely to control for the time and physical attention provided to the experimental group. | Other | Stroking Hand Massage |
Primary outcome
Change in State Anxiety Levels
Time frame: Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Anxiety will be assessed using the State Anxiety Inventory (STAI). The state subscale consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80. Higher scores indicate higher levels of state anxiety.
5 secondary outcomes
Change in Patient Satisfaction
Time frame: Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Change in Hemodynamic Parameters1
Time frame: 1 Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Change in Hemodynamic Parameters 2
Time frame: 2 Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Change in Hemodynamic Parameters 3
Time frame: 3 Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
Change in Hemodynamic Parameters 4
Time frame: 4 Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.
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 19 Oct 2026.
- Results publication1. Abidi, S. M. A., Abbas, S., Abidi, S. T. F., Hussain, N., & Haresh, S. (2023). Application of the Robson classification in assessing cesarean section rates: An audit of a tertiary care hospital's gynecology department in Karachi, Pakistan. medRxiv. https://doi.org/10.1101/2023.04.30.23289336 2. World Health Organization. (2021). Caesarean section rates continue to rise, amid growing inequalities in access. https://www.who.int/news/item/16-06-2021-caesarean-section-rates-continue-to-rise-amid-growing-inequalities-in-access 3. Yang, J. (2025). Cesarean sections in selected countries 2022. Statista. 4. Uğuryol, M., & Dönmez, A. (2022). The effect of reflexology treatment on anxiety. Journal of Psychiatric Nursing, 13(1), 24-30. https://doi.org/10.14744/phd.2021.05579 5. Roshangar, F., Lotfi, M., Aghazadeh, A. M., Asghari, E., & Aghaei, E. (2020). The effect of "nurse companionship" on anxiety and vital sign changes of cesarean section candidates: A randomized control trial. Crescent Journal of Medical and Biological Sciences, 7(2), 267-273. 6. Kunikata H, Watanabe K, Miyoshi M, Tanioka T. The effects measurement of hand massage by the 7. autonomic activity and psychological indicators. Journal of Medical Investigation. 2012;59[1-2]:206-12 8. Aksu, S., & Karaca, P. P. (2021). The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study. Complementary Medicine Research, 28(4), 336-343. 9. Joseph, A., Frank, R. W., & Ramyashree, S. (2024). Postoperative Pain Reduction in "Cesarean Mothers" with Hand and Foot Massage. Journal of Health and Allied Sciences NU, 14(Suppl S1), S18-S20. 10. Kiliçli, A., & Zeyneloglu, S. (2024). Effect of Reflexology on Pain, Fatigue, Sleep Quality, and Lactation in Postpartum Primiparous Women After Cesarean Delivery: A Randomized Controlled Trial. Journal of Human Lactation, 40(2), 221-236. 11. Mahima, A., Saraswathy, K., Venkatesan, L., Vijayalakshmi, K., & Dhanalakshmi, V. (2025). Effective
- 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.
Gizem Göktuna study director
Dokuz Eylul University
Erkan Çağlıyan study director
Dokuz Eylul 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 Reflexology Hand Massage and Stroking Hand Massage in people with Cesarean Section and Anxiety, run by Dokuz Eylul 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. 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. Some participants in this study may receive a placebo. 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 Buse Güler, PhD (+90 232 412 69 70, busebahitli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Levels (time frame: Baseline (before the intervention at the 4th postoperative hour) and 30 minutes after the completion of the 20-minute massage.). 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 NCT07880587, 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 19 Oct 2026.