The Effect of Hand Exercise Hoops on Labour Pain

Официальное название

The Effect of Hand Exercise Hoops on Labour Pain: A Randomized Controlled Single-Blind Study

Обзор

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.

Вмешательства

• Устройство Hand Exercise Hoop
  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, par

Первичные конечные точки

• Labor Pain Intensity [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Within 6 hours after vaginal birth.]

Критерии участия

Критерии включения

• Primiparous women with low-risk pregnancies

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul University - Cerrahpasa — Istanbul

Идентификаторы

NCT: NCT07378449 · 2025/727

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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