PainNCT05764512
Endorphin Massage Application to Women Who Gave Birth Vaginally
A study testing Endorphin massage in people with Pain and Birth, First, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is aimed to determine the effect of endorphin massage applied to puerperant women who had vaginal delivery on pain, comfort, mood and serum beta endorphin levels in the postpartum period. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women only
- Conditions the study is for
- Pain, Birth, First
- What is being tested?
- Endorphin massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 May 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 19 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 37-40. Those who gave birth vaginally in their gestational week,
- In the first 24 hours postpartum,
- Primiparous,
- Episiotomy applied,
- Having a VAS value of at least 5 points,
- Having given birth to a single baby,
Show all 11Show fewer
- Your baby's APGAR Score is between 7-10,
- Skin-tissue integrity,
- No communication problem,
- The spoken language is Turkish,
- Voluntary to participate in the study
Who cannot join
- The baby was admitted to the neonatal intensive care unit,
- Having a cesarean section,
- Experiencing risky labor,
- Postpartum bleeding,
- Epidural analgesia applied
- Having a psychiatric disease (Bipolar Disorder, Depression, Obsessive Compulsive Disorder),
- Having chronic disease (Heart disease, Thyroid problems, Diabetes mellitus, Hypertension, asthma, COPD),
- Postpartum women diagnosed with risky pregnancy (Pre-eclampsia, Eclampsi, Pregnancy-related hypertension, Gestational diabetes, bleeding conditions during pregnancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endorphins Applied to Women Who Have Delivered Vaginally Effect of Massage on Pain
In this study, it is aimed to determine the effect of endorphin massage applied to puerperant women who had vaginal delivery on pain, comfort, mood and serum beta endorphin levels in the postpartum period.
Read the detailed description
Massage application provides an increase in the level of endorphins by making a relaxing effect on the muscles. Endorphin massage increases the release of endorphins, allowing the individual to relax, relax the muscles and reduce pain. Endorphin massage is a light massage technique that can increase the release of oxytocin and endorphin hormones, providing a feeling of calmness and comfort. In addition to reducing pain, the endorphin hormone provides relaxation, supports the immune system, and accelerates metabolic activities. It is also known as the happiness hormone.
It is stated that back massage will increase the release of endorphin hormones by relaxing the mother. In other studies conducted in the postpartum period, it has been determined that massage applied reduces the severity of pain and stress, and increases the level of comfort.
Studies have shown that endorphin massage applied to pregnant women reduces back pain. In another study, it was determined that deep tissue massage applied to the back area after cesarean section reduced the level of pain. In the other study, it was determined that the endorphin massage applied to the 3rd trimester pregnant women reduced the level of anxiety.
When the literature is examined, no study has been found that examines the effect of endorphin massage applied to puerperant women on pain, comfort, mood and beta endorphin levels in the postpartum period. The fact that endorphin massage is applied to similar areas with both back massage and oxytocin massage suggests that endorphin massage may affect the pain process experienced in the postpartum period. It is aimed to determine the effect on endorphin level.
- Conditions
- Pain, Birth, First
- Being tested
- Endorphin massage
- Keywords
- Birth, Vaginal Birth, Massage, Pain, Endorphin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endorphin massageOther
With the anterior surface of the fingertips of the hand, a "V" will be drawn slowly, starting from the sacral region and towards the ribs. The same process will be continued from the sacral region until the 7th cervical vertebra.
From the 7th cervical vertebra, the front surface of the fingertips will be descended first to the shoulders and then to the dorsal region of the upper and forearms in turn.
Starting from the dorsal region of the forearm, the first stage of the massage will end by descending to the upper arm, shoulders, 7th cervical vertebra, spine and sacral region with the back of the thumbs. These massage steps will be repeated until 20 minutes are completed.
Endorphin massage will be applied every 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Is the group to which endorphin massage will be applied. Endorphin massage is a gentle touch and massage method that can improve the relaxation state in the body through the skin surface. Receives: Other: Endorphin massage |
| Control gruop | No intervention | No application will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It is a commonly used scale to measure pain. It consists of a 10 cm ruler on which the patient marks the pain, showing that there is no pain at one end and unbearable pain at the other end. The distance between the point where the patient marked the pain and the pain-free interval is measured in cm and recorded.
In addition, this scale is used to measure comfort. The VAS, which will be used to determine the level of comfort, consists of a ruler of 0 to 10 cm, as well as the level of pain. VAS; 0 = very comfortable, 10 = extremely uncomfortable. In the calculation of the comfort score, the distance between the place marked by the puerperant as "I am comfortable" and the place marked as "I am uncomfortable" is measured and recorded in cm. In this research, the Visual Analog Scale is used to measure both pain level and comfort level.
Measured: two hours
Brief Mood Introspection Scale
In the 16-item scale, the items consist of the emotion adjective and aim to evaluate the current emotional state of the participants. By obtaining two types of scores with the scale, positive (8 items) and negative (8 items) mood levels of the participants are determined. High scores for both mood states indicate high positive or negative emotions. The highest score for both moods is 32 and the lowest score is 8.
Measured: two hours
Serum Beta Endorphin Level
Blood samples are taken from the puerperal women by following the antiseptic rules, into a yellow-capped and gelled blood tube (3-4 mL) by the researcher. The blood tubes are kept at room temperature and in an upright position for 30 minutes. Samples sent to the laboratory are centrifuged at 4000 rpm for 10 minutes. The serum obtained after centrifugation is taken from the blood tubes, put into eppendorf tubes and stored frozen at -80 degrees.
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Feb 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two gruops with intervention gruop and control grup.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurseli Soylu Erener, TC Erciyes University
- Investigators
- Nurseli SOYLU ERENER, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764512
- Sponsor's protocol ID
- 2023/09
- Status last verified
- May 2024
- First submitted
- 1 Mar 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do not share until the article is published.
Publications
Guney E, Ucar T. Effects of deep tissue massage on pain and comfort after cesarean: A randomized controlled trial. Complement Ther Clin Pract. 2021 May;43:101320. doi: 10.1016/j.ctcp.2021.101320. Epub 2021 Jan 28.
PubMed 33548749
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endorphins Applied to Women Who Have Delivered Vaginally Effect of Massage on Pain
- ClinicalTrials.gov ID
- NCT05764512
- Acronym / sponsor ID
- 2023/09
- Conditions
- Pain, Birth, First
- Keywords
- Birth, Vaginal Birth, Massage, Pain, Endorphin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 10 Mar 2023 (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 this study, it is aimed to determine the effect of endorphin massage applied to puerperant women who had vaginal delivery on pain, comfort, mood and serum beta endorphin levels in the postpartum period.
Detailed description
Massage application provides an increase in the level of endorphins by making a relaxing effect on the muscles. Endorphin massage increases the release of endorphins, allowing the individual to relax, relax the muscles and reduce pain. Endorphin massage is a light massage technique that can increase the release of oxytocin and endorphin hormones, providing a feeling of calmness and comfort. In addition to reducing pain, the endorphin hormone provides relaxation, supports the immune system, and accelerates metabolic activities. It is also known as the happiness hormone.
It is stated that back massage will increase the release of endorphin hormones by relaxing the mother. In other studies conducted in the postpartum period, it has been determined that massage applied reduces the severity of pain and stress, and increases the level of comfort.
Studies have shown that endorphin massage applied to pregnant women reduces back pain. In another study, it was determined that deep tissue massage applied to the back area after cesarean section reduced the level of pain. In the other study, it was determined that the endorphin massage applied to the 3rd trimester pregnant women reduced the level of anxiety.
When the literature is examined, no study has been found that examines the effect of endorphin massage applied to puerperant women on pain, comfort, mood and beta endorphin levels in the postpartum period. The fact that endorphin massage is applied to similar areas with both back massage and oxytocin massage suggests that endorphin massage may affect the pain process experienced in the postpartum period. It is aimed to determine the effect on endorphin level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two gruops with intervention gruop and control grup.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Endorphin massageIs the group to which endorphin massage will be applied. Endorphin massage is a gentle touch and massage method that can improve the relaxation state in the body through the skin surface. |
| Control gruop | No intervention | –No application will be made. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 37-40. Those who gave birth vaginally in their gestational week,
- In the first 24 hours postpartum,
- Primiparous,
- Episiotomy applied,
- Having a VAS value of at least 5 points,
Key exclusion criteria (8 listed)
- The baby was admitted to the neonatal intensive care unit,
- Having a cesarean section,
- Experiencing risky labor,
- Postpartum bleeding,
- Epidural analgesia applied
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 |
|---|---|---|
| Endorphin massageWith the anterior surface of the fingertips of the hand, a "V" will be drawn slowly, starting from the sacral region and towards the ribs. The same process will be continued from the sacral region until the 7th cervical vertebra. From the 7th cervical vertebra, the front surface of the fingertips will be descended first to the shoulders and then to the dorsal region of the upper and forearms in turn. Starting from the dorsal region of the forearm, the first stage of the massage will end by descending to the upper arm, shoulders, 7th cervical vertebra, spine and sacral region with the back of the thumbs. These massage steps will be repeated until 20 minutes are completed. Endorphin massage will be applied every 2 hours. | Other | Intervention group |
Primary outcome
Visual Analog Scale
Time frame: two hours
It is a commonly used scale to measure pain. It consists of a 10 cm ruler on which the patient marks the pain, showing that there is no pain at one end and unbearable pain at the other end. The distance between the point where the patient marked the pain and the pain-free interval is measured in cm and recorded. In addition, this scale is used to measure comfort. The VAS, which will be used to determine the level of comfort, consists of a ruler of 0 to 10 cm, as well as the level of pain. VAS; 0 = very comfortable, 10 = extremely uncomfortable. In the calculation of the comfort score, the distance between the place marked by the puerperant as "I am comfortable" and the place marked as "I am uncomfortable" is measured and recorded in cm. In this research, the Visual Analog Scale is used to measure both pain level and comfort level.
Brief Mood Introspection Scale
Time frame: two hours
In the 16-item scale, the items consist of the emotion adjective and aim to evaluate the current emotional state of the participants. By obtaining two types of scores with the scale, positive (8 items) and negative (8 items) mood levels of the participants are determined. High scores for both mood states indicate high positive or negative emotions. The highest score for both moods is 32 and the lowest score is 8.
Serum Beta Endorphin Level
Time frame: two hours
Blood samples are taken from the puerperal women by following the antiseptic rules, into a yellow-capped and gelled blood tube (3-4 mL) by the researcher. The blood tubes are kept at room temperature and in an upright position for 30 minutes. Samples sent to the laboratory are centrifuged at 4000 rpm for 10 minutes. The serum obtained after centrifugation is taken from the blood tubes, put into eppendorf tubes and stored frozen at -80 degrees.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 33548749Guney E, Ucar T. Effects of deep tissue massage on pain and comfort after cesarean: A randomized controlled trial. Complement Ther Clin Pract. 2021 May;43:101320. doi: 10.1016/j.ctcp.2021.101320. Epub 2021 Jan 28.
- Individual participant dataSharing planned: No. Do not share until the article is published.
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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.
Nurseli SOYLU ERENER principal investigator
TC Erciyes 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 Endorphin massage in people with Pain and Birth, First, run by TC Erciyes 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 21 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: two hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764512, which also lists 1 linked publication.
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 21 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.