NCT07389668

Brief Summary

The aim of this study is to determine the effect of the use of hand massage stimulation techniques on nausea-vomiting severity and quality of life in pregnant women diagnosed with hyperemesis gravidarum. Research Hypotheses H1-a: The use of hand massage stimulation techniques in pregnant women diagnosed with hyperemesis gravidarum reduces the severity of nausea-vomiting. H1-b: The use of hand massage stimulation techniques in pregnant women diagnosed with hyperemesis gravidarum increases the quality of life. Data will be collected from pregnant women diagnosed with hyperemesis gravidarum in the maternity ward. It will be ensured that the midwifery intervention is implemented in a way that does not disrupt the examination routine. Seed therapy (su-jok) will be applied by researcher Esra Nur Emre, 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
70

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

Nausea-vomitingquality of lifepregnancymassagemidwife

Outcome Measures

Primary Outcomes (1)

  • Nausea-vomiting severity scores

    The Pregnancy Nausea and Vomiting Severity Assessment Test (PUQE) is a scoring system used to measure the severity of nausea and vomiting during pregnancy. The lowest score on the scale is 3 and the highest is 15. 0-3 indicates no symptoms, 4-6 indicates mild, 7-12 indicates moderate and 13-15 indicates severe nausea and vomiting during pregnancy.

    Data collection forms were administered by the researcher using face-to-face interviews in the first stage (days 1-2 and 3), telephone interviews in the second stage (day 15), and face-to-face interviews again in the third stage (days 30-31).

Secondary Outcomes (1)

  • Quality of life scores

    Data collection forms were administered by the researcher using face-to-face interviews in the first stage (days 1-2 and 3), telephone interviews in the second stage (day 15), and face-to-face interviews again in the third stage (days 30-31) .

Study Arms (2)

Standard maintenance

NO INTERVENTION

Group not receiving seed therapy (su jok)

seed therapy (su jok)

EXPERIMENTAL

Group that received seed therapy (su jok)

Other: 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,
  • Who can read and write,
  • Who do not have any psychiatric disorders,
  • Who are not experiencing a risky pregnancy,
  • Who are hospitalized with a diagnosis of hyperemesis gravidarum,
  • Who do not react negatively to any interventions aimed at touch, such as massage,
  • Who have full and healthy tissue integrity in the area where the massage will be performed

You may not qualify if:

  • Those whose pregnancy has ended for any reason,
  • Those who have not been hospitalized despite being diagnosed,
  • Pregnant women in the third trimester of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

Related Links

Study Officials

  • Esra GÜNEY, PhD

    İnonu Üniversity

    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: randomized controlled trial conducted with experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD 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