Postpartum DisorderNCT06200649
The Effect of Back Massage Applied to Mothers in the Early Postpartum Period on Parameters
A study testing massage in people with Postpartum Disorder, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Disorder
- What is being tested?
- massage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaraş, Necip Fazıl City Hospital Gynecology and Pediatrics Additional Service Building
Kahramanmaraş, 46040
Gamze Şahbaz Çadır, +90 5067494670
Nülüfer Erbil, +90 5358306357, nulufererbil@gmail.com
About this study
Official title: The Effect of Back Massage Applied to Mothers in the Early Postpartum Period on Comfort, Pain, Anxiety, and Physiological Parameters
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.
- Conditions
- Postpartum Disorder
- Being tested
- massage
- Keywords
- Postpartum Period, Mother, Massage, Comfort, Pain, Anxiety, Physiological Parameters, Nursing
- Medical subject headings
- Puerperal Disorders, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start14 Feb 2023
- Primary completion9 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze ŞAHBAZ ÇADIR, Ordu University
- Investigators
- Gamze Şahbaz Çadır, PHD STUDENT, Principal investigator, Ordu UniversityNülüfer Erbil, Prof. Dr., Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200649
- Sponsor's protocol ID
- OUCADIR001
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Back Massage Applied to Mothers in the Early Postpartum Period on Comfort, Pain, Anxiety, and Physiological Parameters
- ClinicalTrials.gov ID
- NCT06200649
- Acronym / sponsor ID
- OUCADIR001
- Conditions
- Postpartum Disorder
- Keywords
- Postpartum Period, Mother, Massage, Comfort, Pain, Anxiety, Physiological Parameters, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 9 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: massageMassage 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18 and over
- Vaginal delivery
- In the first 24 hours after birth
- First born
- Having no difficulty in sitting
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massageMassage 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. | Other | Intervention Group |
Primary outcome
Postpartum Comfort Scale
Time frame: two year
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.
1 secondary outcome
Visual Analogue Scale
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Şahbaz Çadır, PHD STUDENT principal investigator
Ordu University
Nülüfer Erbil, Prof. Dr. study director
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage in people with Postpartum Disorder, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamze ŞAHBAZ ÇADIR (+90 5067494670, Gamze.sahbaz46@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Comfort Scale (time frame: two year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.