NCT06179966

Brief Summary

Pregnancy and the moment of birth are important processes that women will remember throughout their lives and will always leave a mark on their lives. Birth pain is expressed as the most severe pain that women experience throughout their lives (although there is no standard measure due to the combination of different factors). Labor pain; It differs from other types of pain in that it is part of the natural process, occurs within a limited period of time, and the mother willingly endures this pain due to factors such as reuniting with her baby at the end of the process. Due to the possible negative effects of labor pain on maternal and fetal health, the American Society of Anesthesiologists (ASA) and the American Congress of Obstetricians and Gynecologists (ACOG) accept labor pain as an indication that should be treated. recommends that this pain be taken under control. Nowadays, non-pharmacological methods such as "massage, pilates ball, music therapy, acupuncture, aromatherapy" are widely used to manage pain during birth. Massage, which is among the non-pharmacological methods, is the oldest treatment and sensual stimulation method in the world. Massage is generally the first choice method because it has no side effects and is easy to apply. Studies have shown that massage applied during birth provides physical and psychological relief, reduces pain, anxiety, agitation and depressive mood, and increases maternal satisfaction. Determining birth satisfaction is important as it is an indicator of the health status of the mother and newborn as well as the quality of intrapartum care.Birth dance is a combination of music therapy and freedom of movement methods, which is one of the non-pharmacological methods. Birth dance begins in the active phase of the first stage of labor in order to reduce the pain perceived by the woman and to provide emotional support, and continues until the end of the first stage. The woman is given the opportunity to move rhythmically with someone she prefers (spouse/partner, mother, midwife, etc.), accompanied by relaxing light music. In addition to the music and body movements included in the dance, it is aimed to increase the effectiveness of the applied method by adding spouse/partner support and upright positions and at the same time to provide emotional support to the woman.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

December 12, 2023

Last Update Submit

June 4, 2024

Conditions

Keywords

massagedanceendorphin massagepostpartum comfort

Outcome Measures

Primary Outcomes (1)

  • Introductory Information Form

    sociodemographic characteristics, medical and obstetric pregnancy history, the woman's current pregnancy, prenatal and postpartum period

    1 hour

Secondary Outcomes (4)

  • Visual Comparison Scale

    during the birth

  • Postpartum Comfort Scale

    6 hours after birth

  • Person-Centered Maternity Care Scale

    6 hours after birth

  • Birth Satisfaction Scale

    2 hours after birth

Study Arms (3)

Dance group

EXPERIMENTAL

The application will be taught to the participants' spouses by the researcher after they are admitted to labor, and the spouses will be asked to do it to the participants at regular intervals.

Other: Dance group

Massage group

EXPERIMENTAL

After admission to travaya, the researcher will teach the pregnant woman's husband practically and the spouses will massage the participants' backs at certain intervals.

Other: Massage group

Control Group

NO INTERVENTION

Routine midwifery care will be provided, and no applications other than routine midwifery care will be performed.

Interventions

The application will be taught to the participants' spouses by the researcher after they are admitted to labor, and the spouses will be asked to do it to the participants at regular intervals.

Dance group

After admission to travaya, the researcher will teach the pregnant woman's husband practically and the spouses will massage the participants' backs at certain intervals.

Massage group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • knowing Turkish
  • Being over 18 years old
  • Having a second vaginal birth
  • Being able to go through the labor process with his/her spouse
  • Dilation ≤5cm during vaginal examination during admission to labor
  • Pregnancy period is between 36-40 weeks
  • Agreeing to participate in the research with a voluntary consent form
  • Do not use any non-pharmacological method before admission to labor. not to have used
  • Not using any analgesic or anesthetic medication during labor.

You may not qualify if:

  • Having any chronic disease (DM, HT, Heart Disease)
  • Receiving psychiatric treatment (Pharmacotherapy and/or Psychotherapy)
  • Presence of a risky pregnancy that prevents normal birth (oligohydramnios, polyhydramnios, twin pregnancy, placental anomalies, presentation and position anomalies)
  • Presence of a wound that disrupts skin integrity
  • Having given birth 3 or more times
  • Being the first pregnancy
  • Exceeding term (\>40 weeks) or premature birth (\<36 weeks)
  • Presence of previous uterine surgery (caesarean section indication)
  • Not having a partner during labor
  • Have the necessary examination findings to be accepted into the specified research.
  • not having
  • The birth process ends with a cesarean section
  • Having an operative birth (vacuum, forceps)
  • Wants to leave the research voluntarily.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdag Corlu State Hospital

Tekirdağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • KÜBRA YAVAS

    TEKIRDAG CORLU STATE HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssociate professor

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 22, 2023

Study Start

March 3, 2023

Primary Completion

May 1, 2024

Study Completion

May 5, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Locations