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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04977713
Other study ID # KirklareliAS-4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2019
Est. completion date January 31, 2020

Study information

Verified date July 2021
Source Kirklareli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study was aimed that acupressure applied on the BL32 point and shower application reduced the intensity of labor pain experienced by the pregnant women in the active phase of labor and increased their postpartum comfort


Description:

Acupressure and shower are methods that can help reduce pain severity. This study thus aims to determine the effects of acupressure and shower on labour pain and postpartum comfort. This study was a randomized controlled trial (RCT). This study was the control group consisted of 40 pregnant women, while the experimental groups (acupressure and shower) consisted of 80 pregnant women in total. The experimental groups received routine labour care and either acupressure or showers upon reaching three cervical dilations (4-5, 6-7 and 8-10 cm). The control group only received routine labour care. A maternal information form (MIF), the Visual Analog Scale for Pain (VASP) and the Postpartum Comfort Questionnaire (PPCQ) were used to collect data. CONSORT checklist was used to report the current study.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 31, 2020
Est. primary completion date January 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - The inclusion criteria were being 20-40 years of age; - Having a foetus in vertex presentation - Having a foetus weighing 2.5-4 kg, as determined through ultrasonography - Being primiparous - Being between 37 and 42 gestational weeks with a single foetus - Having planned to have a spontaneous vaginal delivery - Not having used nonpharmacological pain control methods previously - Having a cervical dilation less than 5 cm (Dabiri et al., 2014) - Not having received analgesia or anaesthesia. Exclusion Criteria: - Were having a systemic disease during pregnancy (gestational diabetes, hypertension) - Taking medication regularly - Having a problem that prevented the woman from communicating - Undergoing psychiatric treatment (pharmacotherapy or psychotherapy) - Requiring an operative vaginal delivery (forceps, vacuum) - Receiving pharmacological interventions for labour pain.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acupressure
A researcher sat behind the women to comfortably access the sacral area and be in the appropriate position. The researcher then applied deep rotational pressure on the BL32 points until her nail bed colour changed to prevent any discomfort in the participants
Shower
During uterine contractions, these participants took a shower while standing, with a researcher on hand to assist her (average time: 20 minutes). The water's temperature was between 22°C and 26°C.

Locations

Country Name City State
Turkey Medipol University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Kirklareli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduce labor pain The participants were applicated acupressure, and shower as for birth pain. Pain has been evaluated with VASP. Evaluation was done until delivery (on average between 8-12 hours)
Primary Postpartum comfort levels Postpartum comfort levels of the groups who received acupressure and shower in the postpartum period were evaluated.Postpartum comfort level has been evaluated with PPCQ. 2 hours after birth
Primary A maternal information form This form consisted of 13 items asking for the participants' sociodemographic characteristics before birth
Primary Visual Analog Scale for Pain (VASP) This scale is a 0-10 cm ruler developed by Bond and Pilowsky (Hawker et al., 2011; Aslan and Öztürk, 2014; Kömürcü and Ergin, 2014; Bond and Pilowsky, 1996). VASP is a 10 cm ruler which assessment with "no pain" at one end and "worst pain" at the other end. A Turkish validity and reliability study of the VASP was performed by Aslan and Öztürk (Aslan and Öztürk, 2014; Kömürcü and Ergin, 2014; Aslan, 2004). Evaluation was done until delivery (on average between 8-12 hours)
Primary Postpartum Comfort Questionnaire (PPCQ) The 48-item General Comfort Scale, developed by Kolcaba (Kolcaba, 1994), was first adapted into Turkish in 2008 by Kuguoglu and Karabacak, who also conducted a Turkish validity and reliability study on the scale (Kuguoglu and Karabacak, 2008). Based on the Turkish version of the GCS, Karakaplan and Yildiz (Karakaplan and Yildiz, 2010) developed the PPCQ. The PPCQ is a 5-point questionnaire with 34 items. Participants give items between 1 (strongly agree) and 5 points (strongly disagree). The lowest score possible is 34, and the highest score is 170, with higher scores indicating higher comfort levels. 2 hours after birth
Primary Evalution labour pain VASP was evaluated before and after acupressure and shower applications. Evaluation was done until delivery (on average between 8-12 hours)
Primary Evalution postpartum comfort Postpartum Comfort levels were evaluated in the postpartum period. 2 hours after birth
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