Postpartum FatigueBAM-CBNCT07867561
Back Massage for Postpartum Fatigue and Maternity Blues After Cesarean Birth
A study testing Back Massage in people with Postpartum Fatigue and Maternity Blues, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effects of back massage applied after elective cesarean birth on postpartum fatigue and maternity blues. Women were randomly assigned to either a back massage group or a control group. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Fatigue, Maternity Blues
- What is being tested?
- Back Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2025to 10 May 2026
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who underwent elective cesarean birth
- Women with a single healthy newborn
- Women who did not have a negative response to massage or touch interventions
- Women with intact skin and tissue integrity in the back area where the massage was applied
Who cannot join
- Women with communication problems
- Women who underwent cesarean birth under general anesthesia
- Women diagnosed during pregnancy or birth with complications such as oligohydramnios, preeclampsia, heart disease, diabetes, or placenta previa
- Women who developed postpartum complications such as hemorrhage or hypertension
- Women whose newborn required admission to the neonatal intensive care unit
- Women who received additional analgesic or narcotic medication other than the routine postoperative analgesic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Back Massage on Postpartum Fatigue and Maternity Blues Following Elective Cesarean Birth: A Randomized Controlled Trial
This randomized controlled trial evaluated the effects of back massage applied after elective cesarean birth on postpartum fatigue and maternity blues. Women were randomly assigned to either a back massage group or a control group. The intervention group received a 30-minute back massage after the first postoperative mobilization, while the control group received routine postpartum care only. Postpartum fatigue and maternity blues were assessed on the second postoperative day before discharge.
Read the detailed description
This study was conducted as a two-group, parallel, randomized controlled trial to evaluate the effects of back massage applied after elective cesarean birth on postpartum fatigue and maternity blues. The study included 80 women who underwent elective cesarean birth and met the eligibility criteria. Participants were randomly assigned in a 1:1 ratio to either the back massage group or the control group.
Women in the back massage group received routine postpartum care in addition to a 30-minute back massage. The massage was administered by the second author after the first mobilization at the sixth postoperative hour. Women in the control group received routine postpartum care only and did not receive any additional intervention.
Postpartum fatigue and maternity blues were assessed on the second postoperative day before hospital discharge. Postpartum fatigue was evaluated using the Postnatal Accumulated Fatigue Scale, and maternity blues was assessed using the Maternity Blues Scale. Sociodemographic and obstetric characteristics were collected using a Participant Information Form developed by the researchers.
The primary objective of the study was to determine whether back massage after elective cesarean birth reduces postpartum fatigue and maternity blues compared with routine postpartum care alone.
- Conditions
- Postpartum Fatigue, Maternity Blues
- Being tested
- Back Massage
- Keywords
- Back Massage, Cesarean Birth, Postpartum Fatigue, Maternity Blues, Postpartum Care, Nonpharmacological Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back MassageBehavioural
Participants in the Back Massage Group received a 30-minute back massage in addition to routine postpartum care. The massage was administered after the first mobilization at the sixth postoperative hour following elective cesarean birth. The intervention was delivered by the second researcher. Participants continued to receive the hospital's standard postpartum care throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Back Massage Group | Experimental | Participants assigned to the Back Massage Group received routine postpartum care plus a 30-minute back massage. The massage was administered after the first mobilization at the sixth postoperative hour following elective cesarean birth. Postpartum fatigue and maternity blues were assessed on the second postoperative day before discharge. Receives: Behavioral: Back Massage |
| Control Group | No intervention | Participants assigned to the Control Group received the hospital's routine postpartum care only and did not receive any additional intervention. Postpartum fatigue and maternity blues were assessed on the second postoperative day before discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Fatigue Assessed by the Postnatal Accumulated Fatigue Scale
The Postnatal Accumulated Fatigue Scale consists of 13 items and three subscales. Total scores range from 0 to 39, with higher scores indicating greater postpartum fatigue.
Measured: 48 hours after cesarean birth
Maternity Blues Assessed by the Maternity Blues Scale
The Turkish version of the Maternity Blues Scale consists of 28 items and five subscales. Higher scores indicate higher levels of maternity blues.
Measured: 48 hours after cesarean birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start10 May 2025
- Primary completion10 May 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum FatigueStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups: the back massage group or the control group. Participants in the back massage group received a 30-minute back massage in addition to routine postpartum care, while participants in the control group received routine postpartum care only.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Dilek Aksoy, Kocaeli University
- Investigators
- Sena Dilek Aksoy, Ph.D., Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867561
- Sponsor's protocol ID
- BACKMASSAGE-RCT-2025-01
- Acronym
- BAM-CB
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Back Massage on Postpartum Fatigue and Maternity Blues Following Elective Cesarean Birth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07867561
- Acronym / sponsor ID
- BAM-CB / BACKMASSAGE-RCT-2025-01
- Conditions
- Postpartum Fatigue, Maternity Blues
- Keywords
- Back Massage, Cesarean Birth, Postpartum Fatigue, Maternity Blues, Postpartum Care, Nonpharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 10 May 2025 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 9 Oct 2026 (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.
This randomized controlled trial evaluated the effects of back massage applied after elective cesarean birth on postpartum fatigue and maternity blues. Women were randomly assigned to either a back massage group or a control group. The intervention group received a 30-minute back massage after the first postoperative mobilization, while the control group received routine postpartum care only. Postpartum fatigue and maternity blues were assessed on the second postoperative day before discharge.
Detailed description
This study was conducted as a two-group, parallel, randomized controlled trial to evaluate the effects of back massage applied after elective cesarean birth on postpartum fatigue and maternity blues. The study included 80 women who underwent elective cesarean birth and met the eligibility criteria. Participants were randomly assigned in a 1:1 ratio to either the back massage group or the control group.
Women in the back massage group received routine postpartum care in addition to a 30-minute back massage. The massage was administered by the second author after the first mobilization at the sixth postoperative hour. Women in the control group received routine postpartum care only and did not receive any additional intervention.
Postpartum fatigue and maternity blues were assessed on the second postoperative day before hospital discharge. Postpartum fatigue was evaluated using the Postnatal Accumulated Fatigue Scale, and maternity blues was assessed using the Maternity Blues Scale. Sociodemographic and obstetric characteristics were collected using a Participant Information Form developed by the researchers.
The primary objective of the study was to determine whether back massage after elective cesarean birth reduces postpartum fatigue and maternity blues compared with routine postpartum care alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups: the back massage group or the control group. Participants in the back massage group received a 30-minute back massage in addition to routine postpartum care, while participants in the control group received routine postpartum care only.
| Arm | Type | Receives |
|---|---|---|
| Back Massage Group | Experimental | Behavioral: Back MassageParticipants assigned to the Back Massage Group received routine postpartum care plus a 30-minute back massage. The massage was administered after the first mobilization at the sixth postoperative hour following elective cesarean birth. Postpartum fatigue and maternity blues were assessed on the second postoperative day before discharge. |
| Control Group | No intervention | –Participants assigned to the Control Group received the hospital's routine postpartum care only and did not receive any additional intervention. Postpartum fatigue and maternity blues were assessed on the second postoperative day before discharge. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women who underwent elective cesarean birth
- Women with a single healthy newborn
- Women who did not have a negative response to massage or touch interventions
- Women with intact skin and tissue integrity in the back area where the massage was applied
Key exclusion criteria (6 listed)
- Women with communication problems
- Women who underwent cesarean birth under general anesthesia
- Women diagnosed during pregnancy or birth with complications such as oligohydramnios, preeclampsia, heart disease, diabetes, or placenta previa
- Women who developed postpartum complications such as hemorrhage or hypertension
- Women whose newborn required admission to the neonatal intensive care unit
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 |
|---|---|---|
| Back MassageParticipants in the Back Massage Group received a 30-minute back massage in addition to routine postpartum care. The massage was administered after the first mobilization at the sixth postoperative hour following elective cesarean birth. The intervention was delivered by the second researcher. Participants continued to receive the hospital's standard postpartum care throughout the study. | Behavioural | Back Massage Group |
Primary outcome
Postpartum Fatigue Assessed by the Postnatal Accumulated Fatigue Scale
Time frame: 48 hours after cesarean birth
The Postnatal Accumulated Fatigue Scale consists of 13 items and three subscales. Total scores range from 0 to 39, with higher scores indicating greater postpartum fatigue.
Maternity Blues Assessed by the Maternity Blues Scale
Time frame: 48 hours after cesarean birth
The Turkish version of the Maternity Blues Scale consists of 28 items and five subscales. Higher scores indicate higher levels of maternity blues.
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 9 Oct 2026.
- 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.
Sena Dilek Aksoy, Ph.D. principal investigator
Kocaeli 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 Back Massage in people with Postpartum Fatigue and Maternity Blues, run by Kocaeli 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 4 inclusion and 6 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 9 Oct 2026. 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?
Postpartum Fatigue Assessed by the Postnatal Accumulated Fatigue Scale (time frame: 48 hours after cesarean birth). The study lists 2 primary outcomes in all. 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 9 Oct 2026.