Labour Pain
Conditions
Keywords
acupuncture, labour, pain, pain relief, complementary
Brief summary
The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain.
Detailed description
Acupuncture is used in obstetric care in spite of insufficient evidence of its potential to reduce labour pain. The findings so far are contradictory, which may reflect methodological limitations. The present study will take issues into account, such as sufficiently large sample to allow detection of possible differences between study groups; optimal timing of the intervention; controlling for intensity of the treatment; qualified training of persons giving the treatment; biological markers of pain and stress; possible effects on mother and infant; women's experiences such as overall birth experience and memory of pain.
Interventions
DEVICEManual Acupuncture
The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
DEVICEElectro Acupuncture
The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.
Sponsors
University of Skövde
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Admission to the labour ward in spontaneous onset of labour * Latent or active phase of labour * Nulliparity * Singleton pregnancy, cephalic presentation * Gestation: 37+0 to 41+6 (weeks + days) * Expressed need for labour pain relief * Swedish speaking (well enough to understand written and oral instructions)
Exclusion criteria
* No pharmacological pain relief within 24 hours prior to inclusion into the study * Severe preeclampsia * Treatment with oxytocin at the time point of allocation * Treatment with anticoagulant * Pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Epidural Analgesia | From start of treatment until birth | Frequecy of epidural analgesia |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Manual Acupuncture Manual stimulation
Manual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. | 99 |
| Electro Acupuncture Electrical and manual stimulation
Electro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold. | 103 |
| Standard Care No acupunture | 101 |
| Total | 303 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Women's request (31), high workload (8), returned home (4), partus in one hour (1), other (6) | 16 | 16 | 18 |
Baseline characteristics
| Characteristic | Manual Acupuncture | Electro Acupuncture | Standard Care | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 99 Participants | 103 Participants | 101 Participants | 303 Participants |
| Region of Enrollment Sweden | 99 participants | 103 participants | 101 participants | 303 participants |
| Sex: Female, Male Female | 99 Participants | 103 Participants | 101 Participants | 303 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 99 / 99 | 103 / 103 | 101 / 101 |
| other Total, other adverse events | 0 / 99 | 0 / 103 | 0 / 101 |
| serious Total, serious adverse events | 0 / 99 | 0 / 103 | 0 / 101 |
Outcome results
Primary
Use of Epidural Analgesia
Frequecy of epidural analgesia
Time frame: From start of treatment until birth
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual Acupuncture | Use of Epidural Analgesia | 99 participants |
| Electro Acupuncture | Use of Epidural Analgesia | 103 participants |
| Standard Care | Use of Epidural Analgesia | 101 participants |