NCT06421233

Brief Summary

The postpartum period, especially in the first few weeks, can be a difficult period for mothers to adapt to the new situation of having a baby. During this process, physiological, psychological and social changes occur in the mother's body. While many mothers adapt to these changes easily, some mothers may experience psychological disorders at different levels.Among these, anxiety and depression are the most common diseases. Anxiety can negatively affect mothers, especially during birth and the postpartum period.During the postpartum period, nurses have the opportunity to improve maternal and infant health by recognizing and treating anxiety.Physical symptoms associated with postpartum anxiety include fatigue, irritability, difficulty concentrating, and sleep disturbances. However, during the vaginal birth process, mothers may feel tired in the early postpartum period, as the pregnant woman spends a lot of energy by staying hungry for a long time. When the literature was examined, it was determined that endorphin massage reduces back pain in pregnant women, reduces anxiety level in pregnant women, accelerates the involution process in the postpartum period, and has positive effects on postpartum depression.Similar to endorphin massage, it has been determined that back massage reduces back pain in the postpartum period and provides the mother with both physiological and psychological relief. In addition, no study has been found examining the effect of endorphin massage applied to postpartum women on anxiety levels and fatigue in the postpartum period. Therefore, this study aimed to determine the effect of endorphin massage applied to postpartum women who gave birth vaginally on postpartum anxiety and fatigue levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

September 4, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 8, 2024

Last Update Submit

May 15, 2024

Conditions

Keywords

BirthVaginal BirthMassageanxietyEndorphinFatigue

Outcome Measures

Primary Outcomes (1)

  • State and Trait Anxiety Scale

    The state anxiety scale determines how the individual feels at a certain moment and under certain conditions. The scale consists of 20 questions and is asked to choose one of the options 'not at all', 'somewhat', 'a lot' and 'completely' depending on the severity of the thoughts or behaviors. The trait anxiety scale determines how the individual feels, regardless of the situation and conditions, and consists of 20 questions. In answering this scale, one is asked to choose one of the following options: 'almost never', 'sometimes', 'most of the time' and 'almost always', depending on the frequency of the thoughts or behaviors.

    It was applied twice in total, two hours apart.

Secondary Outcomes (1)

  • Visual Similarity Scale for Fatigue

    It was applied twice in total, two hours apart.

Study Arms (2)

Intervention group

EXPERIMENTAL

* Personal introduction form, state and trait anxiety scale and visual similarity scale for fatigue were applied. * Endorphin massage was applied twice by the researcher for 15 minutes every two hours. * After the endorphin massage applied for the second time, the visual similarity scale and the state and trait anxiety scale were applied again for fatigue.

Other: massage

Control gruop

NO INTERVENTION

* A personal introduction form, state and trait anxiety scale, and visual similarity scale for fatigue were applied. * Two hours after the first evaluation, the visual similarity scale and the state and trait anxiety scale were applied again for fatigue.

Interventions

massageOTHER

Endorphin massage will be given for 15 minutes every 2 hours.

Also known as: endorphin massage
Intervention group

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Giving birth vaginally at term,
  • Postpartum within 24 hours,
  • Primiparous,
  • Those who are healthy and have given birth to a single baby,
  • Postpartum women who volunteered to participate in the study were included.

You may not qualify if:

  • Those with psychiatric illness (Bipolar Disorder, Depression, Obsessive Compulsive Disorder),
  • People with chronic diseases (Heart disease, Thyroid problems, Diabetes mellitus, Hypertension, asthma, COPD,
  • Those who have been diagnosed with a risky pregnancy (Pre-eclampsia, Arthritis, Pregnancy-related hypertension, Gestational diabetes),
  • Whose baby was admitted to neonatal intensive care,
  • Postpartum women with postpartum bleeding were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital

Kocasinan, Kayseri, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Anxiety DisordersFatigue

Interventions

Massage

Condition Hierarchy (Ancestors)

Mental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Nurseli SOYLU ERENER

    TC Erciyes University

    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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 20, 2024

Study Start

September 4, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Only the name of the research can be shared.

Locations