Eighty patients were enrolled in this clinical trial. Seventeen participants were not allocated for randomization because of declined to participate or not meeting inclusion criteria, and 63 patients were randomly assigned (allocation ratio one to one) to one of three groups: active TENS1, active TENS2 or placebo TENS. Figure 1 shows the progression of the participants through the trial.
The mean age (standard deviation) of participants was 28.14 years old (5.53), the mean height was 163.65 centimetres (7.52), and the mean weight was 73.49 kilograms (10.61). There were 50 participants enrolled in the study from the European Union (79%), 44 were from Spain (69.8%), and 13 from non-EU countries (20.6%). Baseline participants and obstetrics characteristics are presented in Table 1.
Most women were married, 31 (49.2%). 17 (27%) were primigravidae and 11 (17.5%) multigravidas with one previous pregnancy and 3 (4.8%) with two previous pregnancies. 23 (26.5%) were living with their partner, 18 (28.6%) primigravidae, 4 (6.3%) multigravidas with one previous pregnant and 1 (1.6%) with two previous pregnancies. Finally, 9 (14.3%) were single, all of them primigravidae. All women had a companion during labour.
The total COMFORTS scale mean score was 171.03 (19.69) with an individual item mean of 4.28, with levels between 3.56 and 4.70. The mean item variance was 0.70, ranging from 0.35 to 1.29. In addition, the results were analysed by sub scales related to education, occupation and childbirth preparation (Table 2). All women enrolled in the trial completed the questionnaires received.
Regarding the level of satisfaction related to parity, nulliparous (44) had an average of 172.54 (11.7), multiparous with one previous pregnancy had an average of 170.33 (11.5), and 181.75 (14.5) for those who had more than one previous pregnancy.
Therefore, women who have had more than one delivery presented the highest level of satisfaction, followed by nulliparous and those who have had a previous pregnancy. Women with one previous pregnancy were the only group with a level of satisfaction below average.
In reference to the results obtained from each of the subscales, we obtained the following data:
Confidence in new-born care:
The mean score was 56.93 (5.4). The group with a higher satisfaction level in new-born care were women with a higher cultural level. Other groups, like a lower cultural level or those who had only completed elementary education presented a lower satisfaction level. Those with a low satisfaction level were also found not to have attended childbirth preparation course.
Therefore, according to this subscale, nulliparous had a lower average than the global group, while the rest had higher values, especially those who had only one previous pregnancy.
The satisfaction level according to accompaniment during the active phase of labour, was higher in women who were accompanied by their husband 57.79 (5.4) than those who were accompanied by other family members 54.94 (5.1).
Postpartum nursing care:
The mean score was 47.53 (4.8). Women who presented levels below average were those with a university degree, unemployed and those who did not attend birth preparation classes. 39 were accompanied by their husband and they had a mean level of satisfaction of 47.41 (4.9), 15 were accompanied by another family member with a mean of 48.86 (3.7), and 9 were accompanied by another person with a mean of 44.57(5.5).
It was observed that the highest mean level of satisfaction corresponded with accompanied women and, in this case, especially by the woman´s mother. Respect to parity, women with more than one pregnancy had higher levels of satisfaction than the rest. In addition, women with a previous pregnancy had levels below average.
The mean score was 42.34 (5.1). Groups who presented levels below average were those with an elementary education only and those unemployed.
Logistics and environment:
The mean score was 25.77 (2.4). Women who presented levels below average were those who had completed middle school education only, active and students, and also, those that did not attend the birth preparation classes.
Satisfaction levels in these two final subscales (new-born care and logistics and environment) in relation with parity showed that those with more than one pregnancy had higher levels of satisfaction than the rest, followed by nulliparous, while women with a previous pregnancy had levels below average.
Levels of satisfaction relating to the person attending the labour: The midwife attended 54 women during delivery, while the gynaecologist attended nine. Regarding the level of satisfaction with respect to the confidence in the new-born care sub-scale, a higher level was observed in those that were attended by the midwife, with a mean of 57.14 (5.6) compared to those who were attended by the gynaecologist, with a mean of 55.66 (4.1).
To detect weaknesses, other factors were analysed such as privacy, 8.61(0.9), provision of information, 13.6 (1.3), if the nursing time received was appropriate, 30.01 (3.4), the quality of food 8.81 (0.96), the number of professionals who attended the women 17.23 (1.7), women companion´s attend 8.71 (0.9). Satisfaction levels were high except in the perception of nursing time received, the number of professionals who attended the patient, and the provision of information. In relation to nursing time received, women with a university degree, 29.71 (7.9) and those with severe pain, 29.13 (3.8) presented levels below average. Regarding the number of professionals who attended the women, women with a university degree, 16.67 (1.9), third level students 16.71 (2.1), women with severe pain 16.91 (1.7) and those who did not attend the birth preparation classes, 16.71 (1.5) presented levels below average. Women with a university degree presented a low level of satisfaction with respect to the provision of information, 13.51 (1.3). Multiparous and nulliparous women did not present significant differences with respect to these factors.
The relationship between the level of satisfaction and pain management:
One woman (1.6%) presented mild pain, 32 (50.8%) moderate pain and 30 (47.6%) severe pain. Women who experienced severe pain had expressed a low level of satisfaction, with a mean of 168.61 (9.8). On the other hand, women with moderate pain had a high level of satisfaction, 175.51 (12.1). Regarding sub-scales, women who presented moderate pain had a higher level of satisfaction on all accounts. (Table 3). However, women with severe pain had a satisfaction level below average, except in the logistics and environment sub-scale. Regarding question number six, which refers to measures for controlling pain during labour, it showed a lower degree of satisfaction in women with severe pain, 3.03 (1.1) than women with moderate pain, 4.53 (0.7).
It should be noted that regardless of the type of pain perception, the satisfaction with the delivery room was high, 4.38 (0.7) in women with moderate pain and 4.7 (0.6) with severe pain, except for the assessment of the lighting of the room, with a lower overall average for women who presented severe pain ,3.72 (0.9).