NCT07389707

Brief Summary

The aim of this study is to determine the effects of hand massage stimulation techniques applied to pregnant women with low back pain on pain and comfort. H1-a: Hand massage stimulation technique applied to pregnant women reduces low back pain. H1-b: Hand massage stimulation technique applied to pregnant women increases comfort Data will be collected from pregnant women who apply to the NST polyclinic and complain of back pain. Midwifery intervention will be implemented in a way that does not disrupt the examination routine. Seed therapy (su-jok) will be applied by researcher Esra Tan, who has a basic level su jok therapy certificate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 27, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

back paincomfortpregnantmassagemidwife

Outcome Measures

Primary Outcomes (1)

  • Prenatal Comfort Scale scores

    The initial version of the scale consisted of 34 items, but was later revised by the authors and shortened to 15 items (21). The short version of the scale consists of 15 items and 5 sub-dimensions. Each item is scored between 0-5 (0=Strongly disagree, 1=Disagree, 2=Undecided, 3=Somewhat agree, 4=Agree, 5=Strongly agree). The scale is evaluated out of a total of 75 points.

    At baseline (pre-intervention) and immediately after completion of seed therapy]

Secondary Outcomes (1)

  • Oswestry Disability Index scores

    At baseline (pre-intervention) and immediately after completion of seed therapy

Study Arms (2)

seed therapy ( su-jok)

EXPERIMENTAL

Group that received seed therapy ( su- jok )

Other: seed therapy (su-jok)

standard maintenance

NO INTERVENTION

group not receiving seed therapy ( su- jok)

Interventions

In hand massage, tiny swellings called "ball conformity" occur on the reflection points of the organs where the complaint occurs on the hands and feet. It is argued that the sensitivity of the relevant point to pressure has a direct correlation with the level of pain in the body part. A rod called a "diagnostic probe" or "diagnostic rod" made of metal, plastic or wood, approximately ten centimeters long, is used to detect the painful point on the hand and foot. After the correct point is detected, various techniques are applied to stimulate these points and ensure the continuation of the energy flow.In this study, the seed massage technique, which does not cause any side effects among the hand massage stimulation methods, requires a basic level certificate for its use, does not require being a health professional, and can be easily applied by anyone, will be used. Seed massage is a method applied by first detecting pain through a probe on the points of the organs reflected on the hand

seed therapy ( su-jok)

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women who are over 18 years old,
  • Able to read and write,
  • Have back pain severity of 45 mm and above according to Visual Analogue Scale (VAS),
  • Aren't experiencing risky pregnancies,
  • Do not have any psychiatric disorders,
  • Have a gestational age of 32 weeks or above,
  • Do not react negatively to any interventions such as massage,
  • Have healthy and complete tissue integrity in the area where the massage will be performed will be included in the sample.

You may not qualify if:

  • Pregnant women with acute or chronic diseases, traumas, or surgical history related to the musculoskeletal or nervous system,
  • Those who have gynecological or urological problems that cause pain during pregnancy (premature birth, pyelonephritis, etc.),
  • Those who use analgesics during pregnancy,
  • Those who have difficulty communicating and mentally ill,
  • Those who have a condition that may prevent written or verbal communication,
  • Those who have maternal and fetal complications in their current pregnancy will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Battalgazi̇, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Esra GÜNEY, PhD

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Crossover Assignment randomized controlled trial conducted with experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master thesis student

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 5, 2026

Study Start

October 15, 2024

Primary Completion

December 15, 2024

Study Completion

January 15, 2025

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Research results will be shared

Locations