| CTRI Number |
CTRI/2025/04/084699 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Process of Care Changes Behavioral Other (Specify) [Reproductive health care & prevention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Acupressure applied by midwives on pregnant women, after Delivery, and for assessing newborn Outcomes at LI4, GB21, and SP6 Acupoints among Women during the First Stage of Labor. |
|
Scientific Title of Study
|
Effects of Midwife-Centered Acupressure (MID-CURE) at LI4, GB21 and SP6 points on Maternal, Delivery and Neonatal outcome among primi-parturient women during first stage of labour admitted in Tertiary care hospital: A Double-Blinded Randomized Sham Controlled Clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Sakila Basnet |
| Designation |
Assitant Professor |
| Affiliation |
Sikkim Manipal College of Nursing, Sikkim Manipal University |
| Address |
Ms Sakila Basnet Sikkim Manipal College of Nursing Sikkim Manipal University 5th mile Tadong,Gangtok
East SIKKIM 737102 India |
| Phone |
08370999458 |
| Fax |
|
| Email |
emerald.basnett@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Barkha Devi |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal College of Nursing, Sikkim Manipal University |
| Address |
Dr Barkha Devi Sikkim Manipal College of Nursing Sikkim Manipal University 5th mile Tadong,Gangtok, Sikkim
East SIKKIM 737102 India |
| Phone |
7479278673 |
| Fax |
|
| Email |
barkha.d@smims.smu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Barkha Devi |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal College of Nursing, Sikkim Manipal University |
| Address |
Dr Barkha Devi Sikkim Manipal College of Nursing Sikkim Manipal University 5th mile Tadong,Gangtok, Sikkim
East SIKKIM 737102 India |
| Phone |
7479278673 |
| Fax |
|
| Email |
barkha.d@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal College of Nursing, Sikkim Manipal University 5th mile Tadong Gangtok Sikkim 737102 |
|
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Primary Sponsor
|
| Name |
Ms Sakila Basnett |
| Address |
Level 2, CRH Building, Sikkim Manipal College of Nursing, Sikkim Manipal University,5th mile Tadong, Gangtok |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self |
Level 2, CRH Building, Sikkim Manipal College of Nursing, Sikkim Manipal University,5th mile Tadong, Gangtok |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Barkha Devi |
Sikkim Manipal College of Nursing, Sikkim Manipal University |
Level 2, CRH Building, Sikkim Manipal College of Nursing, Sikkim Manipal University,5th mile Tadong, Gangtok East SIKKIM |
7479278673
barkha.d@smims.smu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Primi Parturient women in first stage of labour |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Midwife Centered Acupressure (MID-CURE)- LI4 point, GB21 point, SP6 point |
•Midwife Centered Acupressure (MID-CURE): Midwife acupressure involves using specific acupressure techniques during labour and postpartum care to support the birthing process, maternal wellbeing and neonatal wellbeing. In this study it refers to complimentary therapy where Midwife (Researcher) trained in Acupressure techniques on the points such as LI4,GB21 and SP6 as non-invasive method to support primi-parturient women during intra-natal care.
•LI4 point: It refers to the treatment point Acupressure Hugo point (LI4), or Large Intestine 4 located on the back of the hand between the base of the thumb and index finger or on the medial midpoint of the first metacarpal within the skin of the thumb and the index finger.
• GB21 point: It refers to the treatment point Acupressure Jianjing” (GB 21) is in the middle of an imaginary line that runs from the bony prominence of the neck to the top of the shoulder joint. Its at the highest point of the shoulder muscle and at the midpoint of the line which connects the prominent vertebra and the acromion.
•SP6 point: It refers to the treatment point Acupressure Sanyinjiao Point (SP6) located above the ankle, on the backside of the shinbone (lower calf). It’s about the distance of four finger widths above the inner ankle bone
|
| Comparator Agent |
SP6 4, GB21, LI4 and Sham Control Group |
In this study it refers to the Standard care along with acupressure administered to the control group through inactive procedure (touch) that mimics the active procedure of acupressure therapy |
|
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Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primi parturient women in spontaneous labour with intact membrane.
In First stage of labour.
Estimated fetal weight of 2.5 - 4 kgs.
No Significant Medical History or past obstetrics history and without any pregnancy complications.
|
|
| ExclusionCriteria |
| Details |
Primi-parturient women in use of Epidosin, or Tab Misoprost.
Pregnancy after infertility.
With Cognitive deficits or impairments.
Refusal to continue participation in the study, receiving pain relief drugs 3 hours before or during the study, labour induction or enhancement by medication. during the study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To determine the efficacy of Midwife-centered acupressure (MID-CURE) on maternal, delivery, and neonatal outcome among primi-parturient women in the first stage of labour within and between LI4, GB21 and SP6 intervention groups and sham control group |
1 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To estimate the maternal, delivery, and neonatal outcome among primi-parturient women before the application of MID-CURE at LI4, GB21 and SP6 intervention groups and sham control group
2. To determine the difference in maternal, delivery, and neonatal outcome among primi-parturient women after the application of at LI4, GB21 and SP6 intervention groups and sham control group
3. To determine association between maternal, delivery, and neonatal outcome among primi-parturient women in LI4, GB21 and SP6 intervention groups and sham control group with their selected variables.
4. To estimate the Satisfaction with MID-CURE among primi-parturient women after the application of at LI4, GB21 and SP6 intervention groups
|
3 years |
|
|
Target Sample Size
|
Total Sample Size="292" Sample Size from India="292"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Acupressure has been used as a complementary
therapy for labor pain management and to potentially facilitate labor
progression. By using acupressure at specific points, the study seeks to
examine whether it improves maternal and neonatal outcomes and provides a
safer, less invasive alternative to pharmacological pain relief methods. The
randomized controlled design allows for rigorous testing of the hypothesis and
can help establish whether there is a real benefit to acupressure over a sham
treatment. If the study finds positive results, it could lead to the wider
adoption of acupressure as a non-pharmacological tool for managing labor pain
and improving outcomes for both mothers and newborns. The study may also
contribute to the broader understanding of how complementary therapies can be
integrated into maternity care, particularly in settings like tertiary care
hospitals where women may have access to more resources. MID-CURE refers
to a midwife-centered approach to applying acupressure during labor,
particularly at specific acupuncture points. LI4 (Hegu): Known to help
with labor pain relief and facilitate the progression of labor. GB21
(Jianjing): Thought to aid in labor progression and provide pain relief. SP6
(Sanyinjiao): A common point used to help with uterine contractions and
reduce labor pain. The intervention aims to evaluate the effects of acupressure
applied at these points during the first stage of labor. Neither the
participants (women in labor) nor the healthcare providers administering the
acupressure know whether the participant is receiving real acupressure or a
sham (placebo) treatment. Participants are randomly assigned to either the
acupressure treatment group or a control group receiving a sham treatment. This
helps to control for the placebo effect. This is a trial where participants are
assigned to either the treatment or control group to study the outcomes. The
participants are primi-parturient women (women experiencing their first
childbirth) who are in the first stage of labor. This is a critical
phase when labor begins and progresses with regular contractions but before the
cervix fully dilates. Tertiary Care Hospitals: These are advanced
medical centers where high-risk pregnancies and deliveries are managed, and
they typically have specialized personnel like midwives who can provide care
during labor.
|