NCT06200649

Brief Summary

In the literature, there are separate studies on massage, comfort, anxiety, and physiological parameters for massage practice, but there are no studies that measure the physiological parameters of comfort, pain, anxiety, blood pressure, pulse, fever, oxygen saturation, respiratory rate in the early postpartum period. In this study, the effect of back massage applied to mothers in the early postpartum period on comfort, pain, anxiety and physiological parameters will be examined. If it is determined that the massage application, which is easy to apply and effective, has a positive effect on physiological parameters such as comfort, pain, anxiety and blood pressure, pulse, fever, oxygen saturation, respiratory rate, as well as other parameters measured in the postpartum period, it can be used in the field of application. This is where the originality of our work comes from. For this reason, it is aimed to contribute to the literature with this study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

January 9, 2023

Last Update Submit

January 11, 2024

Conditions

Keywords

Postpartum PeriodMotherMassageComfortPainAnxietyPhysiological ParametersNursing

Outcome Measures

Primary Outcomes (1)

  • Postpartum Comfort Scale

    Postpartum Comfort Scale consists of 34 items and is a 5-point Likert type. For each item, wording and scoring ranging from "completely agree" (5 points) to "strongly disagree" (1 point) were used. Accordingly, the lowest score from the scale can be 34 and the highest score can be 170. Positive expressions in the scale (1, 2, 3, 5, 7, 11, 14, 15, 18, 19, 20, 23, 24, 25, 31, 32) are coded as 1: I strongly disagree - 5: I completely agree. In the negative items (4, 6, 8, 9, 10, 12,13, 16, 17, 21, 22, 26, 27, 28, 29, 30, 33, 34), it is reversed as "I totally disagree, 5 I totally agree, 1". coded. The average value is determined by dividing the total score obtained from the scale by the number of items and the result is shown in the 1-5 distribution. Basically, low comfort is expressed as 1 and high comfort is expressed as 5.

    two year

Secondary Outcomes (1)

  • Visual Analogue Scale

    two year

Other Outcomes (2)

  • Physiological Parameters Form

    two year

  • determining postpartum anxiety

    two year

Study Arms (2)

Intervention Group

EXPERIMENTAL

Massage will be applied to the intervention group by the researcher who has received training in classical massage techniques and has a certificate. The massage will start with effusion (stroking) and will end with effleurage (stroking). Baby oil will be used during the massage in order to provide slipperiness and to prevent mothers and babies from being affected by the smell. The oil used will be spread on the back by patting. The massage will last 20 minutes. Post-test data will be obtained by re-filling the forms after 3 hours (6 hours after Normal Birth) for the intervention group to whom massage is applied.

Other: massage

Control group

NO INTERVENTION

No intervention will be made to the control group, and the routine nursing practices of the clinic will continue. Pre-test and post-test will be applied.

Interventions

massageOTHER

Massage application; It will be done on the back, which is the five basic massage areas. Massage application will be started with eflorage. The massage will be continued with petrissage by grasping the subcutaneous tissue and muscle layer with the help of thumb and other fingers, starting from the waist circumference. Petrissage will be applied for 5 minutes. After petrissage, the massage was continued with friction movements, which is the other stage. Friction will be applied for 5 minutes. Tapotment will be done after friction. Tapotman will take 5 minutes. After taping, the entire back area will be finished by efflorescence for 2 minutes, just like at the beginning.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and over
  • Vaginal delivery
  • In the first 24 hours after birth
  • First born
  • Having no difficulty in sitting
  • Written / verbal communication can be established
  • At least primary school graduate
  • Not having any problems during mother's pregnancy
  • Not diagnosed with any psychiatric disease
  • Wound, infection, mass etc. on the back. non
  • Vascular and cardio-thoracic diseases, non-skin diseases
  • Women who agree to participate in the study will be taken into the sample

You may not qualify if:

  • Being under 18 years old
  • Giving birth by cesarean section
  • Receiving controlled analgesia after normal delivery
  • Women with a psychiatric diagnosis will not be included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş, Necip Fazıl City Hospital Gynecology and Pediatrics Additional Service Building

Kahramanmaraş, 46040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Puerperal DisordersPainAnxiety Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gamze Şahbaz Çadır, PHD STUDENT

    Ordu University

    PRINCIPAL INVESTIGATOR
  • Nülüfer Erbil, Prof. Dr.

    Ordu University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It will not be clearly stated to the independent statistician which group the intervention and control group participants are in, the groups will be identified with letters as A-B and sent to the statistician for data analysis. The statistical analysis phase of the study will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Expert Nurse- PhD student

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 11, 2024

Study Start

February 14, 2023

Primary Completion

June 9, 2024

Study Completion

September 30, 2024

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations