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HypothermiaNCT07864376

Effect Of Acupressure On Hypothermıa And Shıverıng After Cesarean Sectıon

A study testing Acupressure in people with Hypothermia and Shivering, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This research was planned to determine the effect of acupressure on hypothermia and shivering after cesarean section. H01: There is no difference in hypothermia findings between women who received acupressure and women in the control group. 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
Hypothermia, Shivering, Postoperative Hypothermia
What is being tested?
Acupressure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Oct 2025to 15 Oct 2026
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 aged 18-35,
  • who underwent elective cesarean section,
  • who received spinal anesthesia,
  • who are classified as ASA I (Normal, healthy person without any disease or systemic problem other than surgical pathology causing a systemic disorder),
  • whose body temperature was between 36-37.5 °C on the morning of the cesarean section,
  • who can speak and understand Turkish,
  • and who agree to participate in the study will be included.

Who cannot join

  • Women diagnosed with high-risk pregnancies,
  • Women with compromised body integrity or contagious skin diseases at the acupressure application site,
  • Women using medications that affect thermoregulation, such as vasodilators,
  • Women experiencing intrapartum complications (such as placental abruption),
  • Women requiring intensive care after a cesarean section,
  • Women who received more than 2500 mL of IV fluids or experienced blood loss exceeding 20% during a cesarean section,
  • Women with a BMI below 18.5 or above 24.9,
  • Women who wish to withdraw from the study at any stage will be excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ebru Buket B ERKEN, LICENCE contact

+90 543 842 54 14

ebrubuket11058@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ondokuz Mayis University

    Samsun, Samsun, 55139

    Ebru B ERKEN, midwife

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effect Of Acupressure On Hypothermıa And Shıverıng After Cesarean Sectıon: Randomized Controlled Trial

This research was planned to determine the effect of acupressure on hypothermia and shivering after cesarean section.

H01: There is no difference in hypothermia findings between women who received acupressure and women in the control group.

Read more

H02: There is no difference in shivering findings between women who received acupressure and women in the control group.

Women who present to the hospital for cesarean delivery and who meet the inclusion criteria and volunteer to participate in the study will be informed, and their verbal and written consent will be obtained. Before the acupressure application, the women will be interviewed face-to-face, and a pregnancy information form will be recorded by the researcher. Subsequently, a vital signs monitoring form, a temperature comfort perception scale, and a shivering level assessment form will be completed.

Acupressure group: Half an hour prior to cesarean delivery, pressure was applied to the Yong Quan point (Kd1), the Chongyang point (ST42) on both feet, and the Zu San Li point (ST36) located under the patella. The application involved applying pressure to both feet simultaneously, first to ST42 and Kd1, then to ST36, for 3 minutes each time using the index finger, followed by a 3-minute rest period. This was repeated three times.

Control group: Women who underwent cesarean section received routine postpartum care procedures.

Read the detailed description

Research Objective This research was planned to determine the effect of acupressure on hypothermia and shivering after cesarean section.

Hypotheses H01: There is no difference in hypothermia findings between women who received acupressure and women in the control group.

H02: There is no difference in shivering findings between women who received acupressure and women in the control group.

MATERIALS AND METHODS Research Design This research is a randomized controlled experimental study. Location and Time of Study The research will be conducted between July 15, 2025 and July 15, 2026 at the Ondokuz Mayıs University Health Application and Research Center in northern Turkey, with women who will undergo cesarean delivery in the obstetrics and gynecology department.

Study Population and Sample The study population will consist of women hospitalized in the obstetrics and gynecology ward for cesarean section at Ondokuz Mayıs University Health Application and Research Center. The sample size was calculated using the G*Power 3.1.9.2 program, taking into account the data from the study by Moysés et al. (2014). Using the mean and standard deviation values of the T120 min axillary body temperature of the experimental and control groups in that study, the effect size was calculated as 0.58. The minimum number of individuals to be included in the sample of this study was calculated using G*Power 3.1.9.2 with an effect size of 0.58, α= 0.05, and power: 0.80, and the sample size was determined as 96 women (acupressure group: 48, control group: 48). Considering possible data loss in the study, the sample size was increased by 10% to increase the analytical power, and it was determined that 106 women (acupressure group: 53, control group: 53) would be included in the study. The group assignments for each participant will be determined using a fully randomization technique via the website https://www.randomlists.com/team-generator.

The sample size for this study was calculated using the G*Power 3.1.9.2 program, taking into account the data from the study by Cantürk et al. (2019). The effect size was calculated as 0.82 using the mean and standard deviation of the postoperative tympanic temperature measurements of the experimental and control groups in that study. The minimum number of individuals required for this study's sample was calculated using G*Power 3.1.9.2 with an effect size of 0.82, α= 0.05, and power: 0.80, resulting in a sample size of 50 women (acupressure group: 25, control group: 25). Considering potential data loss, and to increase the analytical power, the sample size was increased by 20%, resulting in the inclusion of 60 women (acupressure group: 30, control group: 30).

Inclusion criteria for the study:

  • Women aged 18-35 years,
  • Women who underwent elective cesarean section,
  • Women who received spinal anesthesia,
  • Women who are classified as ASA I (Normal, healthy person without any disease or systemic problem other than surgical pathology causing a systemic disorder),
  • Women whose body temperature is between 36-37.5 °C on the morning of cesarean section,
  • Women who can speak and understand Turkish,
  • Women who agree to participate in the study will be included.

Exclusion criteria for the study:

  • Diagnosed with a high-risk pregnancy,
  • Having a compromised body integrity or contagious skin disease at the acupressure application site,
  • Using medications that affect thermoregulation, such as vasodilators,
  • Developing intrapartum complications (such as placental abruption),
  • Requiring intensive care after a cesarean section,
  • Receiving more than 2500 mL of IV fluids or experiencing blood loss exceeding 20% during a cesarean section,
  • Having a BMI below 18.5 or above 24.9,
  • Women who wish to withdraw from the study at any stage will be excluded. Data Collection Tools The research data will be collected using the Pregnant Women Introduction Form, Vital Signs Monitoring Form, Temperature Comfort Perception Scale, and Shivering Level Assessment Form.

Pregnant Women Introduction Form: The form was created by the researcher after reviewing the literature. This form consists of a total of 30 questions: 9 questions covering the socio-demographic characteristics of women (age, education level, employment status, etc.) and 21 questions covering their obstetric characteristics (gestational week, number of pregnancies, etc.). While the socio-demographic and some obstetric characteristics (the first 12 questions in the obstetric characteristics section) included in this form will be completed face-to-face before cesarean section, other obstetric characteristics will be written by referring to the patient's file.

Vital Signs Monitoring Form: This form was created by the researcher after reviewing the literature. This form records fever, pulse rate, respiratory rate, blood pressure, and oxygen saturation. The women's vital signs will be monitored and recorded by the researcher before the surgery begins, at the start of the surgery, and at 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes post-surgery.

Temperature Comfort Perception Scale: The Temperature Comfort Perception Scale, is a visual analog scale designed to objectively assess individuals' comfort levels regarding temperature. This scale is scored from zero (too cold) to ten (too hot) based on the individual's own perception. A score of five represents ideal temperature comfort.The thermal comfort perception scale for women will be recorded by the researcher before the start of the surgery, at the beginning of the surgery, and at 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes post-surgery.

Tremor Level Assessment Form: The form, developed to assess individuals' tremor levels through observation, was prepared by the researcher as a questionnaire. This form allows for the objective determination of the individual's tremor severity and is evaluated as follows: 0 (no tremor), 1 (localized tremor in the abdomen and neck), 2 (tremor including the upper extremities), 3 (whole body tremor). The shivering assessment scale will be administered to the women before the surgery begins, at the start of the surgery, and at 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes post-surgery, and the results will be recorded by the researcher.

Acupressure Group: Half an hour before cesarean delivery, acupressure was applied to the Yong Quan point (Kd1), the Chongyang point (ST42), and the Zu San Li point (ST36) located under the patella on both feet (Figure 1, Figure 2, and Figure 3). The application was performed by applying pressure to both feet simultaneously, applying consecutive pressure with the index finger to points ST42 and Kd1, then to point ST36, for 3 minutes, followed by a 3-minute rest period, and repeated 3 times. The duration and intensity of acupressure were determined based on previous studies on the subject. The consecutive pressures were applied at a frequency that would not disturb the person or induce pain, and that would have a calming effect. After cesarean delivery, the Vital Signs Monitoring Form, the Temperature Comfort Perception Scale, and the Shivering Level Assessment Form were completed.

Yong Quan Point (Kd1) is one of the points located on the kidney meridian. On the body, it is situated on the sole of the foot, at the point where the front 1/3 and back 2/3 of the line connecting the base of the 2nd and 3rd toes to the heel intersect.

The Chongyang point (ST42) is located on the sole of the foot, at the point where the front 1/3 and back 2/3 of the line connecting the bases of the 2nd and 3rd toes to the heel meet.

The Zu San Li point (ST36) is located one finger width lateral to the anterior border of the tibia, 3 inches below the patella.

In the control group: Women who underwent routine postpartum care after cesarean delivery completed the Vital Signs Monitoring Form, the Temperature Comfort Perception Scale, and the Shivering Level Assessment Form.

Being tested
Acupressure
Keywords
Acupressure, Cesarean Section, Hypothermia, Shivering
Medical subject headings
Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupressureBehavioural

    Also called Yong Quan Point (Kd1), Chongyang Point (ST42), Zu San Li Point (ST36)

    While international literature contains studies demonstrating the effects of applications such as electric blankets, negative pressure heating, and intravenous fluid heating on hypothermia and shivering, no studies have been found examining the effect of acupressure on hypothermia and shivering after cesarean delivery. Therefore, this research was deemed necessary. The aim of this study is to determine the effect of acupressure on hypothermia and shivering after cesarean delivery.

Study groups in NCT07864376
Study groupRoleWhat they receive
AcupressureExperimentalAcupressure Group: Half an hour before cesarean delivery, acupressure was applied to the Yong Quan point (Kd1), the Chongyang point (ST42) on both feet, and the Zu San Li point (ST36) located under the patella. The application involved applying pressure to both feet simultaneously, first to ST42 and Kd1, then to ST36, for 3 minutes using the index finger, followed by a 3-minute rest period. This was repeated three times. The duration and intensity of the acupressure were determined based on previous studies on the subject. The consecutive pressures were applied at a calming frequency that would not cause discomfort or pain to the patient.
Receives: Behavioral: Acupressure
ControlNo interventionRoutine postpartum care procedures were applied to women after cesarean section.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hypothermia

    Vital Signs Monitoring Form: This form was created by the researcher after reviewing the literature. This form records fever, pulse rate, respiratory rate, blood pressure, and oxygen saturation. Body temperature will be measured using a calibrated digital thermometer. Participants' body temperatures will be measured at baseline and after the acupressure application, and the changes between the groups will be compared. Results will be reported as mean and standard deviation in degrees Celsius (°C).

    Measured: The women's vital signs will be monitored and recorded by the researcher before the surgery begins, at the start of the surgery, and at 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes post-surgery.

Secondary outcomes (1)
  1. tremor

    Tremor Level Assessment Form: The form, developed to assess individuals' tremor levels through observation, was prepared by the researcher as a questionnaire. This form allows for the objective determination of the individual's tremor severity and is evaluated as follows: 0 (no tremor), 1 (localized tremor in the abdomen and neck), 2 (tremor including the upper extremities), 3 (whole body tremor).

    Measured: The shivering assessment scale will be administered to the women before the surgery begins, at the start of the surgery, and at 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes post-surgery, and the results will be recorded by the researcher.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start14 Oct 2025
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion15 Oct 2026 (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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomly selected group received acupressure treatment, while another group served as a control group and received no intervention.
Masking
None (open label)
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07864376
Sponsor's protocol ID
2025/340
Status last verified
Aug 2026
First submitted
13 Sep 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Su, Q., Jiang, Z., Pan, D., et al. (2019). Study on the intervention of hot point foot acupuncture for hypothermia recovery after general anesthesia in patients with cancer. Chinese Journal of General Practice, 17(2), 325-328.

Questions about this trial

What is this clinical trial studying?

A study testing Acupressure in people with Hypothermia and Shivering, run by Ondokuz Mayıs 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 8 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 7 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. 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 Ebru Buket B ERKEN, LICENCE (+90 543 842 54 14, ebrubuket11058@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hypothermia (time frame: The women's vital signs will be monitored and recorded by the researcher before the surgery begins, at the start of the surgery, and at 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes post-surgery.). 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 NCT07864376, 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 7 Oct 2026.

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