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ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases.
Material and Methods: 168 termed, healthy women who admitted to Istanbul GaziosmanpaÅŸa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sterile Water Injection | Experimental | Participants randomised to the intervention group received 4 intracutaneous injections of 0.1 ml sterile water into the skin surrounding the Michaelis rhomboid over the sacral area. |
|
| Dry Injection | Placebo Comparator | Participants in the control group received 4 dry injections in the same region using an insulin needle . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile Water | Other | 0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores-30 | In pain scoring Visual Analog Scale was used | at 30 mins after interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores-10 | In pain scoring Visual Analog Scale was used | at 10 mins after interventions |
| Pain scores-60 | In pain scoring Visual Analog Scale was used |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 13, 2016 | |
| Reset | Oct 7, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 13, 2016 | Oct 7, 2016 |
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dry Injections | Other | dry injections into the skin surrounding the Michaelis rhomboid over the sacral area. |
|
| at 60 mins after interventions |
| Pain scores-90 | In pain scoring Visual Analog Scale was used | at 90 mins after interventions |
| Pain scores-120 | In pain scoring Visual Analog Scale was used | at 120 mins after interventions |
| Pain scores-180 | In pain scoring Visual Analog Scale was used | at 180 mins after interventions |
| APGAR score of neonate | at 5 mins after birth |
| Maternal satisfaction | Likelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others | at 1 hour after birth |
| Rates of breastfeeding-1 | In breastfeed scoring The Infant Breastfeeding Assessment Tool was used | at 1 hour after birth |
| Rates of breastfeeding-24 | In breastfeed scoring The Infant Breastfeeding Assessment Tool was used | at 24.hours after birth |