ClinicalTrials.gg
RecruitingNCT06200649Updated Jan 16, 2024

The Effect of Back Massage Applied to Mothers in the Early Postpartum Period on Parameters

An interventional study of massage in Postpartum Disorder, sponsored by T.C. ORDU ÜNİVERSİTESİ. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by T.C. ORDU ÜNİVERSİTESİ · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

For this purpose, pharmacological and non-pharmacological interventions should be made for these conditions seen in the postpartum period. It is possible to increase the quality of health care, to make a difference in patient care results and clinical practices, to increase patient satisfaction rates and to standardize care, especially by using non-pharmacological methods whose effectiveness has been proven by health professionals. As a matter of fact, studies indicate that postpartum women who receive effective nursing care are highly satisfied (88-90%) with the care services they receive. It is important for health professionals to follow current and high-evidence studies, conduct research on their own development and participate in in-service programs in order to increase the quality of health care. There are many practices such as aromatherapy and yoga applied in the postpartum period. Massage is one of them.

Massage is a process applied systematically to the soft tissues of the body, providing relaxation and mental relief. Theoretically, massage stimulates peripheral receptors in the skin. The stimuli reach the brain via the spinal cord and provide general relaxation. Massage reduces cortisol, adrenaline and noradrenaline levels by regulating the autonomic nervous system. The amygdala may also modulate neural activity in the forebrain and control network. The pressure in massage application increases blood circulation and lymphatic drainage, causing changes in heart rate and blood pressure. This non-pharmacological method helps to increase comfort by relaxing the muscles, increase the release of endorphins, urinary serotonin and dopamine, decrease salivary and urinary cortisol levels, reduce pain and edema, and treat psychological disorders such as depression and anxiety. 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 and respiratory rate, as well as other parameters measured in the postpartum period, it can be used in the application area. This is where the originality of our work comes from. For this reason, it is aimed to contribute to the literature with this study.

02

Conditions studied

  • Postpartum Disorder

Keywords

  • Postpartum Period
  • Mother
  • Massage
  • Comfort
  • Pain
  • Anxiety
  • Physiological Parameters
  • Nursing
03

In context

Puerperal Disorders

40 studies on the registry are indexed under Puerperal Disorders; 10 are open to participants now.

This study's planned enrollment of 72 is below the median of 81 across 32 interventional studies indexed under Puerperal Disorders.

Browse Puerperal Disorders studies →

Lead sponsor

T.C. ORDU ÜNİVERSİTESİ is the lead sponsor of 87 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    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

  • No intervention
    Control group

    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

  • Othermassage

    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.

06

What researchers measure

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.

    Time frame: two year

Secondary outcomes

  1. Visual Analogue Scale

    The Visual Analog Scale is a one-dimensional scale frequently used to determine people's pain levels. The patient makes a mark on a horizontal or vertical ruler of 10 cm or 100 mm, depending on where he sees fit according to the severity of pain. In the result evaluation, 0 cm was stated as "no pain", 0.5 cm-3 cm was stated as "mild pain", 3.5 cm-6.5 cm was stated as "moderate pain", and 7-10 cm was stated as "severe pain". As the score increases, the pain level increases.

    Time frame: two year

Other outcomes

  1. Physiological Parameters Form

    Physiological parameters are important indicators in the management of the postpartum period and in determining the treatment protocol. Blood pressure, body temperature, heart rate, respiratory rate and oxygen saturation, which are stated as basic life parameters, are parameters that indicate the health status of the person. For this purpose, the Physiological Parameters Form includes blood pressure, body temperature, heart rate, oxygen saturation and respiratory rate.

    Time frame: two year

  2. determining postpartum anxiety

    The scale is a four-point Likert type and consists of two parts: State-Trait Anxiety Inventory and Trait Anxiety Inventory. There are 20 questions in each section. For the State Anxiety Scale, "Not at all" is 1, "Somewhat" is 2, "A lot" is 3, "Completely" is 4; For the trait anxiety inventory, "Almost never" is marked as 1, "Sometimes" is marked as 2, "Most of the time" is marked as 3, and "Almost always" is marked as 4. Scales range from 20 to 80. High scores indicate high anxiety. The scale includes reverse and true expressions. When scoring reverse expressions, those with a weight of 1 are given a score of 4; Those with a weight value of 4 are converted to 1.

    Time frame: two year

07

Study locations

1 of 1 sites recruiting
  • Kahramanmaraş, Necip Fazıl City Hospital Gynecology and Pediatrics Additional Service Building
    Kahramanmaraş, 46040, Turkey
    Recruiting
    • Gamze Şahbaz Çadır · Contact+90 5067494670
    • Nülüfer Erbil · Contactnulufererbil@gmail.com · +90 5358306357
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06200649
Lead sponsor
T.C. ORDU ÜNİVERSİTESİ
Responsible party
Gamze ŞAHBAZ ÇADIR (Expert Nurse- PhD student, T.C. ORDU ÜNİVERSİTESİ) — Principal investigator
First posted
Jan 11, 2024
Start date
Feb 14, 2023
Primary completion
Jun 9, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Jan 16, 2024

Study contacts

Gamze ŞAHBAZ ÇADIR
Contact
Gamze.sahbaz46@hotmail.com
+90 5067494670
Nülüfer Erbil
Contact
nulufererbil@gmail.com
+90 5358306357
Gamze Şahbaz Çadır, PHD STUDENT
principal investigator · T.C. ORDU ÜNİVERSİTESİ
Nülüfer Erbil, Prof. Dr.
study director · T.C. ORDU ÜNİVERSİTESİ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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