Ice Massage Applied to SP6 Point at Labor

NCT05676879 | Completed

• 1 other identifier: BalıkesirK
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: In the study , it was aimed to determine the effect of ice massage applied to SP6 point during labor on labor pain, labor comfort, labor duration, and anxiety. Design: A single blind, randomized controlled experimental trial Setting and Participants: 100 primiparas, 50 in the intervention group and 50 in the control group, with 4-5 cm cervical dilatations were included in the study. Ice massage was applied to the SP6 point of the pregnant women in the intervention group at 4-5 cm, 6-7 cm, and 8-9 cm dilatations during three contractions. Measurement Tools: The Pregnant Information Form, VAS, the Partograph Form, Childbirth Comfort Questionnaire (CCQ), and the State Anxiety Scale were used to collect data.

Conditions

Labor Pain; Labor Comfort; Duration of Labor; Anxiety

Keywords

Labor Pain; SP6 Acupoint; Labor comfort; duration of labor; anxiety

Outcome Measures

Primary Outcomes (1)

• severity of labor pain by VAS

  The scale was used in order to measure labor pain. It is made up of a vertical line ranging from 0 to 10 (Ferreira-Valente et al., 2011). In the study, VAS was applied before the intervention at 4-5 cm cervical dilatation (VAS-I) and after the intervention at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatations (VAS-2, VAS-3, VAS-4, respectively).

  immediately after the intervention

Secondary Outcomes (1)

• duration of labor

  during the procedure

Study Arms (2)

Intervention Group

EXPERIMENTAL

Ice massage was applied to the SP6 points (SP6 point is located 3-4 fingers above the posterior malleolus bone, that is, 4 fingers above the ankle) of the pregnant women in first stage of childbirth at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatations during 3 contractions. In order to prevent direct contact of ice with the skin, ice was applied as ice cubes wrapped in gauze.

Other: Ice massage was applied to the SP6 points

Control Group

NO INTERVENTION

All the pregnant women, those in the control group, were provided with standard midwifery care.

Interventions

Ice massage was applied to the SP6 points OTHER

Ice massage was applied to the SP6 points (SP6 point is located 3-4 fingers above the posterior malleolus bone, that is, 4 fingers above the ankle) of the pregnant women in first stage of childbirth at 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatations during 3 contractions.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• expected vaginal delivery
• single healthy fetus
• primipara
• in the first phase of the labor

You may not qualify if:

• multipara
• risky pregnancy
• child with complications
• multiple pregnancies
• premature delivery

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Hülya Türkmen

Balıkesir, 10100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: December 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)