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Completed

NCT Number: NCT05407103

Acupressure and Comfort at Childbirth

Aims: Non-pharmacological methods employed for management labor pain also help pregnant women to cope with labor pain and increase their childbirth comfort. The aim of this study is to determine the effect of cold and hot acupressure applications, applied to the acupressure point LI4 of primiparous women during labor, on their childbirth comfort.

Methods: This study was designed a randomized controlled experimental study. The sample consisted of 129 healthy pregnant women including 44 pregnant women in the hot acupressure group, 44 pregnant women in the cold acupressure group, and 41 pregnant women in the control group. The "Personal Information Form", the "Labor Monitoring Form", the "Visual Analog Scale", and the "Childbirth Comfort Questionnaire" were all used to gather the data.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Health Research and Training Hospital of Tokat Gaziosmanpaşa University

Tokat Province, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a primipara
  • Having intact membranes
  • No skin diseases (such as urticaria...),
  • No use of narcotic drugs
  • Having a term pregnancy
  • Having a single fetus at vertex position
  • Planning to have vaginal delivery
  • Having contractions and ongoing regular augmentation
  • Having recent augmentation starting periods
  • Being in the latent phase (0-3 cm dilatation)
  • Having no history of high-risk pregnancy
  • Not using analgesic drugs to reduce pain during delivery
  • Having no systemic and neurologic diseases
  • Having no contraction anomaly (hypotonic or hypertonic contractions)

Exclusion criteria

  • Having any of the above criteria

Treatment and study plan

Cold Acupressure

Other

For the cold acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference. Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout. Lastly, the cold acupressure pouches were kept in a freezer for 40 minutes.

Warm Acupressure

Other

For the warm acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference. Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout. Lastly, the warm acupressure pouches were heated in a microwave at 600 W for one minute.

Primary outcomes

  1. Comfort

    Time frame: through study completion, an average of 1month

    Childbirth Comfort Questionnaire (CCQ); Each item ranks between 1 and 5 points: 1=Strongly disagree, 2=Mostly disagree, 3=Partially agree, 4=Mostly agree, and 5=Completely agree. Thus, the lowest and highest scores are 9 and 45 points, respectively. The higher the score one earns, the more comfortable they are; the lower the score, the exact opposite

Secondary outcomes

  1. Labor pain

    Time frame: through study completion, an average of 1month

    Visual Analog Scale (VAS); It is a 10-cm one-dimensional ruler; written on one end is "no pain"; on the other is "worst pain." For the purpose of this study, the researchers used VAS vertically in this study, in line with the recommendations of other studies, who suggest that individuals understand VAS better when applied vertically.

Sponsors and collaborators

Lead sponsor

Serap Ozturk Altinayak

Other

Registry information

Official study title

The Impact of Applying Various Forms of Acupressure on Women's Hand During Labor on Their Childbirth Comfort: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 7, 2022
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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