Labour PainNCT07378449
The Effect of Hand Exercise Hoops on Labour Pain
A study testing Hand Exercise Hoop in people with Labour Pain and Midwifery, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This randomized, single-blind controlled trial aims to evaluate the effect of using a hand exercise ring combined with breathing exercises on labor pain, anxiety, and childbirth satisfaction in primiparous women during the active phase of labor. 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
- Labour Pain, Midwifery
- What is being tested?
- Hand Exercise Hoop
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous women with low-risk pregnancies
Who cannot join
- Women with high-risk pregnancies (such as preeclampsia, placenta previa)
- Women who will use any pharmacological or non-pharmacological pain management method
- Women who cannot be contacted or who are not amenable to referral
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
Istanbul University - Cerrahpasa
Istanbul
Elif DOGAN, +90 539 601 15 88, elifdogann18@gmail.com
About this study
Official title: The Effect of Hand Exercise Hoops on Labour Pain: A Randomized Controlled Single-Blind Study
This randomized, single-blind controlled trial aims to evaluate the effect of using a hand exercise ring combined with breathing exercises on labor pain, anxiety, and childbirth satisfaction in primiparous women during the active phase of labor. Labor pain is a complex, multidimensional experience that intensifies as labor progresses and may lead to adverse physiological, psychological, and emotional consequences for both the mother and the fetus if not effectively managed. While pharmacological pain relief methods are effective, they may be associated with maternal and neonatal side effects and are not always accessible. Therefore, safe, low-cost, and non-pharmacological pain management strategies are of growing interest in maternity care.
The study will be conducted in a hospital labor ward and will include low-risk primiparous women aged 18-35 years who are admitted for vaginal birth. A total of 86 participants will be randomly assigned to either an intervention group or a control group. Women in the intervention group will receive a soft hand exercise ring and will be instructed to use it in conjunction with guided breathing exercises during uterine contractions, starting at 4-5 cm cervical dilation and continuing throughout the active phase of labor. During each contraction, participants will squeeze the hand exercise ring while exhaling and release it during relaxation periods between contractions. This intervention is designed to reduce pain perception through distraction, activation of the gate control mechanism, increased endorphin release, and regulation of the autonomic nervous system via controlled breathing.
Read more
The control group will receive routine intrapartum care without any additional pain management intervention. Outcome measures include labor pain intensity assessed using the Visual Analog Scale (VAS), anxiety levels measured with the State Anxiety Inventory (STAI Form TX-1), and childbirth satisfaction evaluated using the Maternal Satisfaction with Childbirth Scale. Pain and anxiety will be assessed at three stages of cervical dilation (4-5 cm, 6-7 cm, and 8-9 cm), while childbirth satisfaction will be assessed six hours postpartum.
The findings of this study are expected to contribute evidence regarding the effectiveness of a simple, non-invasive, and easily applicable intervention for labor pain management, potentially supporting its integration into routine midwifery care to improve women's childbirth experiences.
- Conditions
- Labour Pain, Midwifery
- Being tested
- Hand Exercise Hoop
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Exercise HoopDevice
Participants assigned to the intervention group will use a soft hand exercise hoop in combination with guided breathing exercises during the active phase of labor. The intervention will begin at 4-5 cm cervical dilation and continue throughout the active phase. During each uterine contraction, participants will be instructed to inhale deeply at the onset of the contraction and to squeeze the hand exercise hoop while slowly exhaling as the contraction intensifies. As the contraction subsides, participants will release the hoop and return to normal breathing. The hand exercise hoop will be used continuously during contractions as a mechanical distraction and sensory stimulus. The intervention aims to reduce pain perception through activation of the gate control mechanism, distraction from pain stimuli, increased endorphin release, and regulation of the autonomic nervous system via controlled breathing. Participants will receive verbal guidance and support from healthcare staff throughout
| Study group | Role | What they receive |
|---|---|---|
| Hand Exercise Hoop Group | Experimental | Not described Receives: Device: Hand Exercise Hoop |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor Pain Intensity
Labor pain intensity will be assessed using the Visual Analog Scale (VAS), a validated tool consisting of a 10-cm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (10). Participants will indicate their perceived pain intensity at each assessment point, with higher scores indicating greater pain severity.
Measured: During the active phase of labor at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilation (up to 24 hours)
Maternal Anxiety During Labor
Maternal anxiety levels will be measured using the State Anxiety Inventory, a 20-item self-report questionnaire assessing situational anxiety. Total scores range from 20 to 80, with higher scores indicating higher levels of anxiety.
Measured: During the active phase of labor at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilation (up to 24 hours)
Maternal Satisfaction with Childbirth
Maternal satisfaction with the childbirth experience will be evaluated using the Maternal Satisfaction with Childbirth Scale, a validated instrument assessing women's satisfaction with various aspects of the childbirth process. This study will use the vaginal birth version, which contains 43 items and 10 subscales to assess maternal satisfaction during childbirth. The subscales evaluate different areas of satisfaction related to the birth process (e.g., pain management, communication with healthcare personnel, birth environment). The total score range is 43-215. Higher total scores indicate greater satisfaction with the birth experience.
Measured: Within 6 hours after vaginal birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Dogan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378449
- Sponsor's protocol ID
- 2025/727
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Exercise Hoops on Labour Pain: A Randomized Controlled Single-Blind Study
- ClinicalTrials.gov ID
- NCT07378449
- Acronym / sponsor ID
- 2025/727
- Conditions
- Labour Pain, Midwifery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 30 Jan 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.
This randomized, single-blind controlled trial aims to evaluate the effect of using a hand exercise ring combined with breathing exercises on labor pain, anxiety, and childbirth satisfaction in primiparous women during the active phase of labor. Labor pain is a complex, multidimensional experience that intensifies as labor progresses and may lead to adverse physiological, psychological, and emotional consequences for both the mother and the fetus if not effectively managed. While pharmacological pain relief methods are effective, they may be associated with maternal and neonatal side effects and are not always accessible. Therefore, safe, low-cost, and non-pharmacological pain management strategies are of growing interest in maternity care.
The study will be conducted in a hospital labor ward and will include low-risk primiparous women aged 18-35 years who are admitted for vaginal birth. A total of 86 participants will be randomly assigned to either an intervention group or a control group. Women in the intervention group will receive a soft hand exercise ring and will be instructed to use it in conjunction with guided breathing exercises during uterine contractions, starting at 4-5 cm cervical dilation and continuing throughout the active phase of labor. During each contraction, participants will squeeze the hand exercise ring while exhaling and release it during relaxation periods between contractions. This intervention is designed to reduce pain perception through distraction, activation of the gate control mechanism, increased endorphin release, and regulation of the autonomic nervous system via controlled breathing.
The control group will receive routine intrapartum care without any additional pain management intervention. Outcome measures include labor pain intensity assessed using the Visual Analog Scale (VAS), anxiety levels measured with the State Anxiety Inventory (STAI Form TX-1), and childbirth satisfaction evaluated using the Maternal Satisfaction with Childbirth Scale. Pain and anxiety will be assessed at three stages of cervical dilation (4-5 cm, 6-7 cm, and 8-9 cm), while childbirth satisfaction will be assessed six hours postpartum.
The findings of this study are expected to contribute evidence regarding the effectiveness of a simple, non-invasive, and easily applicable intervention for labor pain management, potentially supporting its integration into routine midwifery care to improve women's childbirth experiences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Exercise Hoop Group | Experimental | Device: Hand Exercise Hoop |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primiparous women with low-risk pregnancies
Key exclusion criteria (3 listed)
- Women with high-risk pregnancies (such as preeclampsia, placenta previa)
- Women who will use any pharmacological or non-pharmacological pain management method
- Women who cannot be contacted or who are not amenable to referral
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 |
|---|---|---|
| Hand Exercise HoopParticipants assigned to the intervention group will use a soft hand exercise hoop in combination with guided breathing exercises during the active phase of labor. The intervention will begin at 4-5 cm cervical dilation and continue throughout the active phase. During each uterine contraction, participants will be instructed to inhale deeply at the onset of the contraction and to squeeze the hand exercise hoop while slowly exhaling as the contraction intensifies. As the contraction subsides, participants will release the hoop and return to normal breathing. The hand exercise hoop will be used continuously during contractions as a mechanical distraction and sensory stimulus. The intervention aims to reduce pain perception through activation of the gate control mechanism, distraction from pain stimuli, increased endorphin release, and regulation of the autonomic nervous system via controlled breathing. Participants will receive verbal guidance and support from healthcare staff throughout | Device | Hand Exercise Hoop Group |
Primary outcome
Labor Pain Intensity
Time frame: During the active phase of labor at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilation (up to 24 hours)
Labor pain intensity will be assessed using the Visual Analog Scale (VAS), a validated tool consisting of a 10-cm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (10). Participants will indicate their perceived pain intensity at each assessment point, with higher scores indicating greater pain severity.
Maternal Anxiety During Labor
Time frame: During the active phase of labor at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilation (up to 24 hours)
Maternal anxiety levels will be measured using the State Anxiety Inventory, a 20-item self-report questionnaire assessing situational anxiety. Total scores range from 20 to 80, with higher scores indicating higher levels of anxiety.
Maternal Satisfaction with Childbirth
Time frame: Within 6 hours after vaginal birth.
Maternal satisfaction with the childbirth experience will be evaluated using the Maternal Satisfaction with Childbirth Scale, a validated instrument assessing women's satisfaction with various aspects of the childbirth process. This study will use the vaginal birth version, which contains 43 items and 10 subscales to assess maternal satisfaction during childbirth. The subscales evaluate different areas of satisfaction related to the birth process (e.g., pain management, communication with healthcare personnel, birth environment). The total score range is 43-215. Higher total scores indicate greater satisfaction with the birth experience.
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 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Exercise Hoop in people with Labour Pain and Midwifery, run by Istanbul University - Cerrahpasa 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Jan 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 Elif DOGAN (+90 539 601 15 88, elifdogann18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor Pain Intensity (time frame: During the active phase of labor at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilation (up to 24 hours)). The study lists 3 primary outcomes in all. 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 30 Jan 2026.