NCT04980053

Brief Summary

In the study, selections to the experimental and control groups will be made randomly and simple randomization method will be used. In this context, the individuals included in the research will be assigned to the control and initiative groups respectively and randomized by an expert statistician.The sample of the study was found to be at the 95% confidence interval and at the level of α= 0.05. The effect size was found to be 0.5703 based on previous studies. With a theoretical power of 0.95, the minimum sample size was totally calculated as 51, 17 for the intervention 1 (back massage), 17 for the intervention 2 (breast massage) group and 17 for the control group. However, it was aimed to reach 60 people by predicting that there might be case losses, and it was planned to recruit 20 people for each group. The dependent variables of the study are the amount of breast milk and the level of anxiety. The independent variable is the back and breast massage practice. This research will be carried out in Zonguldak Gynecology and Pediatrics Hospital between 1st July 2021-2022.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

August 6, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

June 20, 2021

Last Update Submit

August 4, 2021

Conditions

Premature Birth

Keywords

breast massagebreast milkback massageoxytocınanxıety

Outcome Measures

Primary Outcomes (31)

  • Amount of Milk

    measured in the breast milk storage bag (ml)

    Change from Amount of Milk 7 Days

  • Level of Anxiety

    The trait anxiety scale, the responses are classified as (1) Not at all, (2) A little, (3) A lot, and (4) Completely; Responses in the trait anxiety scale are classified as (1) almost never, (2) sometimes, (3) often, and (4) almost always. There are two kinds of statements (direct and reversed) in scales. While scoring these statements, those with a score of 1 turn into 4, and those with a score of 4 turn into 1. In direct statements, responses with a value of 4 indicate high anxiety. In reversed statements, responses with a value of 1 indicate high anxiety while those with a value of 4 indicate low anxiety. The scores obtained from both scales range from 20 to 80. The score obtained from the scales constitutes the individual's score to be interpreted at the level of anxiety. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    1th day

  • Level of Anxiety

    The trait anxiety scale, the responses are classified as (1) Not at all, (2) A little, (3) A lot, and (4) Completely; Responses in the trait anxiety scale are classified as (1) almost never, (2) sometimes, (3) often, and (4) almost always. There are two kinds of statements (direct and reversed) in scales. While scoring these statements, those with a score of 1 turn into 4, and those with a score of 4 turn into 1. In direct statements, responses with a value of 4 indicate high anxiety. In reversed statements, responses with a value of 1 indicate high anxiety while those with a value of 4 indicate low anxiety. The scores obtained from both scales range from 20 to 80. The score obtained from the scales constitutes the individual's score to be interpreted at the level of anxiety. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    7th day

  • Level of Anxiety

    The trait anxiety scale, the responses are classified as (1) Not at all, (2) A little, (3) A lot, and (4) Completely; Responses in the trait anxiety scale are classified as (1) almost never, (2) sometimes, (3) often, and (4) almost always. There are two kinds of statements (direct and reversed) in scales. While scoring these statements, those with a score of 1 turn into 4, and those with a score of 4 turn into 1. In direct statements, responses with a value of 4 indicate high anxiety. In reversed statements, responses with a value of 1 indicate high anxiety while those with a value of 4 indicate low anxiety. The scores obtained from both scales range from 20 to 80. The score obtained from the scales constitutes the individual's score to be interpreted at the level of anxiety. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    6th week

  • Socio-demographic characteristics of participant

    education level

    1th day

  • Socio-demographic characteristics of participant

    age

    1th day

  • Socio-demographic characteristics of participant

    region of residence until the age of 15

    1th day

  • Socio-demographic characteristics of participant

    spouse's education level,

    1th day

  • Socio-demographic characteristics of participant

    employment status

    1th day

  • Socio-demographic characteristics of participant

    occupation

    1th day

  • Socio-demographic characteristics of participant

    family type

    1th day

  • Socio-demographic characteristics of participant

    income status

    1th day

  • Fertility characteristics of partıcipant

    number of pregnancies

    1th day

  • Fertility characteristics of partıcipant

    week of birth

    1th day

  • Fertility characteristics of partıcipant

    type of birth

    1th day

  • Fertility characteristics of partıcipant

    the state of oxytocin given at birth

    1th day

  • Fertility characteristics of partıcipant

    encountering problems during pregnancy

    1th day

  • Fertility characteristics of partıcipant

    smoking during pregnancy

    1th day

  • Fertility characteristics of partıcipant

    to take medicine or herbal product usage to increase breast milk

    1th day

  • Fertility characteristics of partıcipant

    the person that make her give birth

    1th day

  • Fertility characteristics of partıcipant

    mother's body mass index (kg/m\^2)

    1th day

  • Fertility characteristics of partıcipant

    mother's weight (kg)

    1th day

  • Fertility characteristics of partıcipant

    mother's weight (cm)

    1th day

  • Fertility characteristics of partıcipant

    to take vitamin in pregnancy

    1th day

  • Fertility characteristics of partıcipant

    to take iron preparation in pregnancy

    1th day

  • Fertility characteristics of partıcipant

    to take breastfeeding education in pregnancy

    1th day

  • Characteristics of baby

    baby's gender

    1th day

  • Characteristics of baby

    birth weight

    1th day

  • Characteristics of baby

    head circumference

    1th day

  • Characteristics of baby

    APGAR score

    1th day

  • Characteristics of baby

    reason for hospitalization

    1th day

Study Arms (3)

Back Massage

EXPERIMENTAL

Back massage will be initiated in the first 2 hours after birth and it will be performed every 6 hours for 15 minutes until the mother is discharged from the hospital. After the mother's outfits are removed and the mother is situated in a suitable position, the back of the mother will be massaged by euphlorage, petrissage, friction methods. Then, the participant"s breast will be milked by hand every 3 hours and will be measured in the breast milk storage bag and delivered to the baby nurses until the 5th-7th day.

Other: massage

Breast Massage

EXPERIMENTAL

Breast massage will be initiated in the first 2 hours after delivery and it will be practised every 6 hours until being discharged. After the researcher washes her hands, the participant's outfits are removed and she is situated in a sitting position, the massage will be practised on both breasts for 10 minutes by the researcher herself. After the mother's breast will be milked by hand every 3 hours and the milk obtained from the breast will be measured in the breast milk storage bag and delivered to the baby nurses.

Other: massage

Control Group

NO INTERVENTION

No intervention will be made to the control group, standard hospital procedures will be applied and the relevant forms will be filled out. Until the mother is discharged from the hospital, the amount of milk obtained from the mother will be measured every 3 hours by the researcher.

Interventions

massageOTHER

Intervention group Control group

Also known as: back massage, breast massage
Back MassageBreast Massage

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a caesarean or vaginal delivery for the first time,
  • Giving preterm birth between 32-37 weeks,
  • Having only one baby,
  • Having a baby with an APGAR score above 4,
  • Having the baby in the intensive care unit or being apart from the baby,
  • Not having any psychiatric disease,
  • Being aged 18 and over and having no communication problems such as seeing, hearing or speaking.

You may not qualify if:

  • Having a mental and psychological disorder,
  • being HIV-infected
  • Having a breast surgery before, or having a history of breast cancer,
  • Having breast infection,
  • Living apart from the husband or being divorced,
  • Having lost the baby.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Gynecology and Pediatrics Hospital

Zonguldak, Center, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Şeyma K ERCİYAS

    Ege University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Şeyma K ERCİYAS

CONTACT

5454720162seymakilcisk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In this context, individuals included in the study will be assigned to the control and intervention groups respectively, randomized by an expert statistician and received in closed envelopes.
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 20 for intervention 1 (back massage) group, 20 for intervention 2 (breast massage) group and 20 for control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 20, 2021

First Posted

July 28, 2021

Study Start

August 6, 2021

Primary Completion

March 10, 2022

Study Completion

June 10, 2022

Last Updated

August 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Since this is a doctoral thesis, it is planned to be shared after the thesis is published.

Locations

TU(1)