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The Effect of Hand Exercise Hoops on Labour Pain

I

Istanbul University - Cerrahpasa

Status

Begins enrollment in 3 months

Conditions

Labour Pain
Midwifery

Treatments

Device: Hand Exercise Hoop

Study type

Interventional

Funder types

Other

Identifiers

NCT07378449
2025/727

Details and patient eligibility

About

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.

Enrollment

86 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Primiparous women with low-risk pregnancies

Exclusion criteria

  • 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 design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

86 participants in 2 patient groups

Hand Exercise Hoop Group
Experimental group
Treatment:
Device: Hand Exercise Hoop
Control Group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Elif DOGAN

Data sourced from clinicaltrials.gov

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