Delivery Pain and Postpartum Comfort

NCT04977713 | Completed

• 1 other identifier: KırklareliAS-4
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Labor Pain; Hydrotherapy; Acupressure; Postpartum Period

Keywords

labor pain; shower; acupressure; midwife; postpartum comfort

Outcome Measures

Primary Outcomes (7)

• 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)

• 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

• A maternal information form

  This form consisted of 13 items asking for the participants' sociodemographic characteristics

  before birth

• 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)

• Postpartum Comfort Questionnaire (PPCQ)

  The 48-item General Comfort Scale, developed by Kolcaba (Kolcaba, 1994), was first adapted into Turkish in 2008 by Kuğuoğlu and Karabacak, who also conducted a Turkish validity and reliability study on the scale (Kuğuoğlu and Karabacak, 2008). Based on the Turkish version of the GCS, Karakaplan and Yıldız (Karakaplan and Yıldız, 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

• Evalution labour pain

  VASP was evaluated before and after acupressure and shower applications.

  Evaluation was done until delivery (on average between 8-12 hours)

• Evalution postpartum comfort

  Postpartum Comfort levels were evaluated in the postpartum period.

  2 hours after birth

Study Arms (3)

Acupressure group

EXPERIMENTAL

In the acupressure uterine contractions were checked before the care application began. Acupressure was applied when the women's cervical dilation reached 4-5 cm, 6-7 cm and 8-10 cm. This method was applied 18 times during uterine contractions. The application stopped at the end of each contraction and resumed once another contraction started. No application was performed between contractions.

Other: Acupressure

Shower Group

EXPERIMENTAL

The shower group, uterine contractions were checked before the care application began. A shower was applied when the women's cervical dilation reached 4-5 cm, 6-7 cm and 8-10 cm. This method was applied 18 times during uterine contractions. The application stopped at the end of each contraction and resumed once another contraction started. No application was performed between contractions.

Other: Shower

Control group

NO INTERVENTION

The women in the control group underwent routine hospital care. They were administered neither pharmacological nor nonpharmacological methods to reduce labour pain.

Interventions

Acupressure OTHER

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

Acupressure group

Shower OTHER

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.

Shower Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kırklareli University: lead

Study Sites (1)

Medipol University

Istanbul, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• AYCA SOLT KIRCA, Phd

  Kırklareli University

  PRINCIPAL INVESTIGATOR

• DERYA KANZA GÜL, Md, Phd

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The randomized controlled trial

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 27, 2021
• Study Start: May 15, 2019
• Primary Completion: January 25, 2020
• Study Completion: January 31, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)